ANTIBACTERIAL HAND SANITIZER- zinc pyrithione liquid 
SHANTOU WBM TRADING CO., LTD.

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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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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)

Alcohol 80% 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

79829-101 79829-101

ANTIBACTERIAL HAND SANITIZER 
zinc pyrithione liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79829-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I) (HYDROXIDE ION - UNII:9159UV381P) SODIUM HYDROXIDE0.03   in 100 
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.15   in 100 
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.8   in 100 
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 11 
WATER (UNII: 059QF0KO0R) 78.14 
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.15 
COCO DIETHANOLAMIDE (UNII: 92005F972D) 1.5 
TEA LEAF OIL (UNII: VC855RRT77) 0.2 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79829-101-01460 in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only03/19/2020
Labeler - SHANTOU WBM TRADING CO., LTD. (560081525)

Revised: 8/2020
Document Id: acc19802-7e1a-38e5-e053-2995a90aa835
Set id: acc12f60-6930-2027-e053-2a95a90a64eb
Version: 1
Effective Time: 20200808
 
SHANTOU WBM TRADING CO., LTD.