Label: ANTIBACTERIAL HAND SANITIZER- zinc pyrithione liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 79829-101-01 - Packager: SHANTOU WBM TRADING CO., LTD.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 8, 2020
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL HAND SANITIZER
zinc pyrithione liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79829-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM HYDROXIDE (UNII: 55X04QC32I) (HYDROXIDE ION - UNII:9159UV381P) SODIUM HYDROXIDE 0.03 in 100 PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 0.15 in 100 SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 0.8 in 100 Inactive Ingredients Ingredient Name Strength SODIUM LAURYL SULFATE (UNII: 368GB5141J) 11 WATER (UNII: 059QF0KO0R) 78.14 COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 5 POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U) 3 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.15 COCO DIETHANOLAMIDE (UNII: 92005F972D) 1.5 TEA LEAF OIL (UNII: VC855RRT77) 0.2 Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79829-101-01 460 in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 03/19/2020 Labeler - SHANTOU WBM TRADING CO., LTD. (560081525)