75% HAND SANITIZER- 75% hand sanitizer gel gel, metered 
Zhejiang Gafle Auto Chemical 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.

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74763-019
75% HAND SANITIZER

ACTIVE INGERDIENT

75%Ethyl Alcohol

PURPOSE

Antimicrobial

USES

For hand sanitizing to decrease bacteria on skin.

WARNINGS

FLAMMABLE.KEEP AWAY FROM FIRE OR FLAME.
For external use only.Avoid contact with eyes.If contact occurs， flush eyes immediately with water and call a doctor.

/

Stop use and consulta doctor ii rita tion develops.

KEEP OUT OF REACH OF CHILDREN.
If swallowed， call a poison control centre or get medical help immediately.

Stop use and consulta doctor ii rita tion develops.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.
If swallowed， call a poison control centre or get medical help immediately.

DIRECTIONS

Apply ape a sized amount on to your hand， and rub thoroughly until dry.Use as needed.For children under the age of 6， use with adult supervision.

OTHER INFORMATION

Storeattemperaturesbelow41℃.(106°F)

INACTIVE INGERDIENTS

Purified water， Glycerin， Triethanolamine， Carbomer， VitaminE

Package Label - Principal Display Panel

74763-019-01 Front of outer packaging

74763-019-01 Front of outer packaging

74763-019-01 Back of outer packaging

74763-019-01 Back of outer packaging

74763-019-11 inner packaging

74763-019-11 inner packaging

75% HAND SANITIZER 
75% hand sanitizer gel gel, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74763-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74763-019-014 in 1 BAG04/30/2020
1NDC:74763-019-1130 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/30/2020
Labeler - Zhejiang Gafle Auto Chemical Co., Ltd. (550707836)
Registrant - Zhejiang Gafle Auto Chemical Co., Ltd. (550707836)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Gafle Auto Chemical Co., Ltd.550707836manufacture(74763-019)

Revised: 3/2022
Document Id: db52c692-e8f7-4ad0-e053-2995a90a039a
Set id: b84c6275-a1f9-2c67-e053-2995a90a4a2b
Version: 2
Effective Time: 20220328
 
Zhejiang Gafle Auto Chemical Co., Ltd.