HAND SANITIZER- hand sanitizer gel 
Shantou Wanli Biotechnology 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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Active Ingredient(s)

PROPYL ALCOHOL 75% 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

For external use only. Flammable. 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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

1605060708091011010203

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74928-002
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 1342 (UNII: 809Y72KV36)  
DIGLYCERIN (UNII: 3YC120743U)  
WATER (UNII: 059QF0KO0R)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74928-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
2NDC:74928-002-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
3NDC:74928-002-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
4NDC:74928-002-04200 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
5NDC:74928-002-05250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
6NDC:74928-002-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
7NDC:74928-002-07750 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
8NDC:74928-002-081000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/13/2020
Labeler - Shantou Wanli Biotechnology Co.,Ltd. (544468822)
Establishment
NameAddressID/FEIBusiness Operations
Shantou Wanli Biotechnology Co.,Ltd.544468822manufacture(74928-002)

Revised: 6/2020
Document Id: a7177742-63f4-070d-e053-2a95a90a117e
Set id: a305d255-9668-0854-e053-2995a90ac5f9
Version: 5
Effective Time: 20200602
 
Shantou Wanli Biotechnology Co.,Ltd.