HAND SANITIZER- alcohol gel 
Zhejiang Yuantiao Cosmetics 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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YuanTiao, Hand Sanitizer, Gel, 70% Alcohol

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

Flammable. For external use only. Keep away from heat or flame.

Do not use

When using this product keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Other information

Inactive ingredients

Water, Propylene Glycol, Glycerol, Carbomer, Aminomethyl Propanol

Package Label - Principal Display Panel

55

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74737-2011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL38.5 mL  in 55 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.275 mL  in 55 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.165 mL  in 55 mL
WATER (UNII: 059QF0KO0R) 15.675 mL  in 55 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.275 mL  in 55 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.11 mL  in 55 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74737-2011-8240 in 1 CARTON04/10/2020
1NDC:74737-2011-155 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:74737-2011-048 in 1 CARTON05/20/2020
2NDC:74737-2011-3250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:74737-2011-648 in 1 CARTON05/20/2020
3NDC:74737-2011-4300 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:74737-2011-74 in 1 CARTON05/20/2020
4NDC:74737-2011-53785 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/10/2020
Labeler - Zhejiang Yuantiao Cosmetics Co., Ltd. (413798466)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Yuantiao Cosmetics Co., Ltd.413798466manufacture(74737-2011) , label(74737-2011)

Revised: 5/2020
Document Id: a6797096-651f-c968-e053-2a95a90af76c
Set id: a2f53d77-187a-4fcb-e053-2a95a90a2735
Version: 3
Effective Time: 20200528
 
Zhejiang Yuantiao Cosmetics Co., Ltd.