pain or swelling occurs

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500- pain relief gel gel HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500- menthol usp, 4% lotion HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000- menthol usp, 4% gel Abacus Health Products, Inc.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.

----------Flexible Pain Relief Line

For NDC 73096-071 Harmony Hemp Flexible Pain Relief Lotion 500Harmony HempFlexiblePain Relief LotionMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 8 oz (226.7 g)Menthol USP, 4%Menthol USP, 4%.....................Topical analgesictemporarily relieves minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyWhen using this product

use only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight.

Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurs

symptoms persist for more than 7 days or clear up and occur again within a fewdays

Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older

apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 3 to 4 times daily

children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,water

Questions or comments? 888-949-4367

For NDC 73096-072 Harmony Hemp Flexible Pain Relief Gel 500Harmony HempFlexible Pain Relief GelMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 3 oz (85.05 g)Menthol, USP, 4%

Menthol, USP, 4%................................Topical analgesictemporarily relieves minor pain associated with arthritis, simple backache, musclestrains, sprains, bruises, and crampsFor external use onlyWhen using this product

use only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken, or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurssymptoms persist for more than 7 days or clear up and occur again within a fewdays

Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older

Apply to affected area no more than 3 to 4 times daily

children under 12 years of age: Ask a doctoraloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract,blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leafextract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hempextract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica,tocopheryl acetate, triethanolamine, yellow 5, waterQuestions or comments? 888-949-4367

For NDC 73096-073 Harmony Hemp Flexible Pain Relief Gel 1000Harmony HempFlexible Pain Relief GelMenthol 4%Joint & MuscleCBD Moisturizing Oil1000mg per bottleNet Wt 3 oz (85.05 g)Menthol USP, 4%Menthol USP, 4%...........................Topical analgesictemporarily relieves minor pain associated with arthritis, simple backache, musclestrains, sprains, bruises, and crampsFor external use onlyWhen using this product

use only as directed

do not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken, or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurssymptoms persist for more than 7 days or clear up and occur again within a fewdays

Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older

Apply to affected area no more than 3 to 4 times daily

children under 12 years of age: Ask a doctoraloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract,blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leafextract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hempextract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica,tocopheryl acetate, triethanolamine, yellow 5, waterQuestions or comments? 888-949-4367

For NDC 73096-074 Harmony Hemp Flexible Pain Relief Roll-on 500Harmony HempFlexiblePain Relief Roll-onMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 2.5 oz (70.8 g)Menthol USP, 4%Menthol USP, 4%......................Topical analgesictemporary relief of minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyDo not use

on wounds or damaged skin

When using this productavoid contact with eyes and mucous membranesdo not bandage tightly or use with a heating pad

Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation develops

Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older

Apply to affected area no more than 3 to 4 times dailyWash hands with soap and water after use

children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,waterQuestions or comments? 888-949-4367

For NDC 73096-075 Harmony Hemp Flexible Pain Relief Roll-on 1000Harmony HempFlexiblePain Relief Roll-onMenthol 4%Joint & MuscleCBD Moisturizing Oil1000mg per bottleNet Wt 2.5 oz (70.8 g)Menthol USP, 4%Menthol USP, 4%......................Topical analgesictemporary relief of minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyDo not use

on wounds or damaged skin

When using this productavoid contact with eyes and mucous membranesdo not bandage tightly or use with a heating pad

Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation develops

Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older

Apply to affected area no more than 3 to 4 times dailyWash hands with soap and water after use

children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,waterQuestions or comments? 888-949-4367

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500 menthol usp, 4% gel

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-074

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)

MENTHOL,UNSPECIFIED FORM

2832 mg in 70.8 g

Inactive IngredientsIngredient Name Strength

YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) COTTONSEED OIL (UNII: H3E878020N) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 500 mg in 70.8 gPOLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CLOVE OIL (UNII: 578389D6D0) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y)

JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B)

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:73096-

074-02 1 in 1 CARTON 06/26/2019

1 NDC:73096-074-01

70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not aCombination Product

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part348 06/26/2019

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500 pain relief gel gel

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-072

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)

MENTHOL,UNSPECIFIED FORM

3402 mg in 85.05 g

Inactive IngredientsIngredient Name Strength

FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR, (-)- (UNII: 213N3S8275) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)

ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEMP (UNII: TD1MUT01Q7) 500 mg in 85.05 gTROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:73096-

072-02 1 in 1 CARTON 07/10/2019

1 NDC:73096-072-01

85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not aCombination Product

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part348 07/10/2019

HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500 menthol usp, 4% lotion

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-071

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)

MENTHOL,UNSPECIFIED FORM

9068 mg in 226.7 g

Inactive IngredientsIngredient Name Strength

YELLOW WAX (UNII: 2ZA36H0S2V) COTTONSEED OIL (UNII: H3E878020N) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) WATER (UNII: 059QF0KO0R) CLOVE OIL (UNII: 578389D6D0)

TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 500 mg in 226.7 g

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:73096-

071-01226.7 g in 1 BOTTLE, PUMP; Type 0: Not aCombination Product 06/26/2019

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part348 06/26/2019

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000 menthol usp, 4% gel

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-075

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)

MENTHOL,UNSPECIFIED FORM

2832 mg in 70.8 g

Inactive IngredientsIngredient Name Strength

YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) COTTONSEED OIL (UNII: H3E878020N) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 1000 mg in 70.8 gPOLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CLOVE OIL (UNII: 578389D6D0) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y)

JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B)

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:73096-

075-02 1 in 1 CARTON 06/26/2019

1 NDC:73096-075-01

70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not aCombination Product

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part348 06/26/2019

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000 menthol usp, 4% gel

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-073

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)

MENTHOL,UNSPECIFIED FORM

3402 mg in 85.05 g

Inactive IngredientsIngredient Name Strength

FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR, (-)- (UNII: 213N3S8275) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)

Abacus Health Products, Inc.

ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEMP (UNII: TD1MUT01Q7) 1000 mg in 85.05 gTROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:73096-

073-02 1 in 1 CARTON 07/10/2019

1 NDC:73096-073-01

85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not aCombination Product

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part348 07/10/2019

Labeler - Abacus Health Products, Inc. (116931574)

EstablishmentName Address ID/FEI Business Operations

Aidance Scientific, Inc, DBA Aidance Skincare & TopicalSolutions 018950611 manufacture(73096-071, 73096-074,

73096-075)

EstablishmentName Address ID/FEI Business Operations

Inspec Solutions 081030372 manufacture(73096-072, 73096-073)

Revised: 2/2021