81422-009-50--hand sanitizer spray 50ml
TRANSCRIPT
HAND SANITIZER- hand sanitizer spray spray Shenzhen Lynns Industrial Co., Ltd.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
81422-009 Hand Sanitizer Spray
Active Ingredient(s )75%ethyl alcohol by volume....antimicrobial
Purposeantimicrobial
UseUse to help reduce bacterial on skin.
WarningsFlammable.External use only
Do not use on open skin wounds or children under 2 months of age
When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center rightaway.
Do not useDo not use on open skin wounds or children under 2 months of age
When using this product avoid contact with eyes.If case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center rightaway.
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center rightaway.
Directions·wet hands thoroughly with product and allow to dry without wiping. ·For children under 6, use only under adult supervision.
Other information
Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
Package Label - Principal Display Panel81422-009-00--Hand Sanitizer Spray 500ml
81422-009-37--Hand Sanitizer Spray 1Gallon
HAND SANITIZER hand sanitizer spray spray
Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:8 1422-0 0 9
Route of Adminis tration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength
Shenzhen Lynns Industrial Co., Ltd.
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M) ALCOHOL 75 mL in 10 0 mL
Inactive IngredientsIngredient Name Strength
GLYCERIN (UNII: PDC6 A3C0 OX)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
WATER (UNII: 0 59 QF0 KO0 R)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:8 1422-0 0 9 -0 0 50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20
2 NDC:8 1422-0 0 9 -37 378 5 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20
3 NDC:8 1422-0 0 9 -50 50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 3/30 /20 20
Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC mo no graph no t fina l part333A 0 3/30 /20 20
Labeler - Shenzhen Lynns Indus trial Co., Ltd. (525563756)
EstablishmentName Addre ss ID/FEI Bus ine ss Ope rations
Shenzhen Lynns Industria l Co ., Ltd. 52556 3756 manufacture(8 1422-0 0 9 )
Revised: 1/2021