75% ALCOHOL HAND SANITIZER- alcohol gel 
Dong Guan Lead Silicone Products 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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75% alcohol hand sanitizer-guangdong

This is a hand sanitizer 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 hand sanitizer 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) (75%, 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 (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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)

Ethy 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

  • in children less than 2 months of age
  • on open skin wounds

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

  • 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 between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

30 mL NDC: 77920-001-01

60 mL NDC: 77920-001-02 60ml

100 mL NDC: 77920-001-03

200 mL NDC: 77920-001-04

300 mL NDC: 77920-001-05

500 mL NDC: 77920-001-06

75% ALCOHOL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77920-001
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
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77920-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
2NDC:77920-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
3NDC:77920-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
4NDC:77920-001-04200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
5NDC:77920-001-05300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
6NDC:77920-001-06500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/202011/22/2021
Labeler - Dong Guan Lead Silicone Products Co., Ltd. (543356954)
Registrant - Dong Guan Lead Silicone Products Co., Ltd. (543356954)
Establishment
NameAddressID/FEIBusiness Operations
Dong Guan Lead Silicone Products Co., Ltd.543356954manufacture(77920-001)

Revised: 11/2021
 
Dong Guan Lead Silicone Products Co., Ltd.