ANTISEPTIC HAND SANITIZER GEL- alcohol liquid 
Sanqi Beauty & Hair Care Goods 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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Antiseptic Hand Sanitizer Gel

This is a Antiseptic Hand Sanitizer Gel manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The Antiseptic Hand Sanitizer Gel is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol
  3. Carbomer
  4. Aminomethyl Propanol
  5. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Antiseptic Hand Sanitizer Gel

Use

Antiseptic Hand Sanitizer Gel 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

Aqua
Glycerin
Carbomer
Aminomethyl Propanol

Package Label - Principal Display Panel

60 mL NDC: 75443-101-01

280 mL NDC: 75443-101-02

500 mL NDC: 75443-101-03

60280500

ANTISEPTIC HAND SANITIZER GEL 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75443-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75443-101-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75443-101-02280 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75443-101-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Sanqi Beauty & Hair Care Goods Co., Ltd. (527105070)
Establishment
NameAddressID/FEIBusiness Operations
Sanqi Beauty & Hair Care Goods Co., Ltd.527105070manufacture(75443-101)

Revised: 4/2020
Document Id: a36321f5-3cd7-6100-e053-2995a90a40b3
Set id: a3632f6c-2428-2235-e053-2995a90a7fad
Version: 1
Effective Time: 20200416
 
Sanqi Beauty & Hair Care Goods Co., Ltd.