SHIELD HAND SANITIZER- alcohol gel 
Guangzhou Cluster Mapping Supply Chain 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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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. ethyl Alcohol (75%, 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)

Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial

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

354 ml Label2 FL OZ (60 ml) : 90010-646-02 60 ml Label
8 FL OZ (236 ml) : 90010-646-08 236 ml Label
12 FL OZ (354 ml) : 90010-646-12
1 Liter (1000 ml) : 90010-646-10 1000 ml Label

SHIELD HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90010-646
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:90010-646-0244160 mL in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
2NDC:90010-646-1215060 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/07/2020
3NDC:90010-646-089702 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/07/2020
4NDC:90010-646-1012 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/07/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/07/2020
Labeler - Guangzhou Cluster Mapping Supply Chain Co., Ltd (554544021)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Cluster Mapping Supply Chain Co., Ltd554544021manufacture(90010-646)

Revised: 9/2020
Document Id: aef6663b-0b08-673a-e053-2995a90a966a
Set id: ac0ff05c-9390-2a38-e053-2995a90acb5c
Version: 8
Effective Time: 20200909
 
Guangzhou Cluster Mapping Supply Chain Co., Ltd