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BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIM CHLORIDE (250 CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT)- antibacterial hand wipe cloth 75% ALCOHOL WET WIPES- alcohol wet wipes cloth BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE 0.12% (250 CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE- biopure antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT)- biopure antibacterial hand wipe unscented cloth Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Ethyl Alcohol 75%………………Antisepetic Purified Water USP For external use only. Flammable. Keep away from heat or flame. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use in children less than 2 months of age. Do not use on open wounds. Apply to hands, allow to air dry without wipping. Discard wipe in trash receptable after use. Do not flush. To help reduce bacteria that potentially cause disease. To help reduce bacteria that potentially cause disease

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Page 1: To help reduce bacteria that potentially cause disease

BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIM CHLORIDE (250CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT)- antibacterial handwipe cloth 75% ALCOHOL WET WIPES- alcohol wet wipes cloth BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE 0.12% (250CT)- antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE- biopure antibacterial hand wipe cloth BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT)- biopureantibacterial hand wipe unscented cloth Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.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.

----------Ethyl Alcohol 75%………………AntisepeticPurified Water USPFor external use only. Flammable. Keep away from heat or flame.Keep out of reach of children. If swallowed, get medical help or contact a Poison ControlCenter right away.Do not use in children less than 2 months of age.Do not use on open wounds.Apply to hands, allow to air dry without wipping.Discard wipe in trash receptable after use.Do not flush.To help reduce bacteria that potentially cause disease.To help reduce bacteria that potentially cause disease

Page 2: To help reduce bacteria that potentially cause disease
Page 3: To help reduce bacteria that potentially cause disease
Page 4: To help reduce bacteria that potentially cause disease
Page 5: To help reduce bacteria that potentially cause disease
Page 6: To help reduce bacteria that potentially cause disease

BIOPURE ANTIBACTERIAL HAND WIPE 0.12% BENZALKONIMCHLORIDE (250 CT) antibacterial hand wipe cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-500

Route of Administration TOPICAL

Active Ingredient/Active Moiety

Page 7: To help reduce bacteria that potentially cause disease

Ingredient Name Basis of Strength StrengthBENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)

BENZALKONIUMCHLORIDE

12 in 100

Inactive IngredientsIngredient Name Strength

PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T)

Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-500-

01250 in 1 CANISTER; Type 0: Not a CombinationProduct 10/20/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 10/20/2020

BIOPURE ANTIBACTERIAL HAND WIPE (1400 CT) antibacterial hand wipe cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-300

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)

BENZALKONIUMCHLORIDE

12 in 100

Page 8: To help reduce bacteria that potentially cause disease

Inactive IngredientsIngredient Name Strength

PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)

Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-300-

011400 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 07/23/2020

75% ALCOHOL WET WIPES alcohol wet wipes cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-100

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 in 100

Inactive IngredientsIngredient Name Strength

WATER (UNII: 059QF0KO0R)

Page 9: To help reduce bacteria that potentially cause disease

Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-100-

01100 in 1 CANISTER; Type 0: Not a CombinationProduct 07/23/2020

2 NDC:79794-100-03

120 in 1 CANISTER; Type 0: Not a CombinationProduct 07/23/2020

3 NDC:79794-100-02

80 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 07/23/2020

BIOPURE ANTIBACTERIAL HAND WIPE BENZALKONIUM CHLORIDE0.12% (250 CT) antibacterial hand wipe cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-200

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)

BENZALKONIUMCHLORIDE

12 in 100

Inactive IngredientsIngredient Name Strength

METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T)

Page 10: To help reduce bacteria that potentially cause disease

Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-200-

01250 in 1 PACKAGE; Type 0: Not a CombinationProduct 07/23/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 07/23/2020

BIOPURE ANTIBACTERIAL HAND WIPE biopure antibacterial hand wipe cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-400

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)

BENZALKONIUMCHLORIDE

0.13 in 100

Inactive IngredientsIngredient Name Strength

ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) ALOE (UNII: V5VD430YW9)

Product CharacteristicsColor white Score

Page 11: To help reduce bacteria that potentially cause disease

Color ScoreShape SizeFlavor Imprint CodeContains

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-400-

0140 in 1 POUCH; Type 0: Not a CombinationProduct 09/14/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 09/14/2020

BIOPURE ANTIBACTERIAL HAND WIPE UNSCENTED (1400 CT) biopure antibacterial hand wipe unscented cloth

Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:79794-600

Route of Administration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6JUD5X6Y)

BENZALKONIUMCHLORIDE

12 in 100

Inactive IngredientsIngredient Name Strength

PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R)

Product CharacteristicsColor white Score Shape SizeFlavor Imprint CodeContains

Page 12: To help reduce bacteria that potentially cause disease

Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.

Packaging# Item Code Package Description Marketing Start

DateMarketing End

Date1 NDC:79794-600-

011400 in 1 PACKAGE; Type 0: Not a CombinationProduct 10/20/2020

Marketing InformationMarketingCategory

Application Number or MonographCitation

Marketing StartDate

Marketing EndDate

OTC monograph notfinal part333A 10/20/2020

Labeler - Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd. (723796509)

EstablishmentName Address ID/FEI Business Operations

Zhejiang Furuisen SpunlacedNonwovens Co.,Ltd. 723796509 manufacture(79794-100, 79794-200, 79794-300, 79794-

400, 79794-500, 79794-600)

Revised: 10/2021


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