HAND SANITIZER- hand sanitizer gel 
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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HAND SANITIZER

ACTIVE INGERDIENT

Ethyl Alcohol 70%.

PURPOSE

Antiseptic

USES

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS

For external use only.
Flammable. Keep away from heat or flame. Keep out of reach of children.
If swallowed, get medical help or contact
Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed, get medical help or contact
Poison Control Center right away.

DIRECTIONS

Place enough product on hands to cover all surfaces.

Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swalloWing.

OTHER INFORMATION

Store below 106°F.(41°C)

INACTIVE INGERDIENTS

Purified Water,Glycerin,Triethanolamine,Carbomer,Vitamin E.

Package Label - Principal Display Panel

378060473236

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74763-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74763-002-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
2NDC:74763-002-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
3NDC:74763-002-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
4NDC:74763-002-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
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.,LTD550707836manufacture(74763-002)

Revised: 3/2022
Document Id: db52ca6a-3b3d-2bb2-e053-2995a90aedf5
Set id: a72aa0ad-04d3-22bb-e053-2995a90afd44
Version: 3
Effective Time: 20220328
 
ZHEJIANG GAFLE AUTO CHEMICAL CO.,LTD