Label: HAND GEL SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78851-333-01, 78851-333-02, 78851-333-03, 78851-333-04, view more78851-333-05 - Packager: Allied Pressroom Products
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 19, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is an ethanol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.
It is manufactured by gelling a 70 % ethanol solution with the the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::
- 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.
- Glycerin (1.00 % v/v)..
- Polypropylene Glycol (1.2 % v/v)..
- Acrylate Polymer (0.3% v/v).
- Sterile distilled water or boiled cold water.
No other materials are used.
- 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
HAND GEL SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78851-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 1.2 mL in 100 mL ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB) 0.3 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 1 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78851-333-01 105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2020 2 NDC:78851-333-02 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2020 3 NDC:78851-333-03 240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2020 4 NDC:78851-333-04 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/19/2020 5 NDC:78851-333-05 3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/19/2020 Labeler - Allied Pressroom Products (069895618) Registrant - Allied Pressroom Products (069895618) Establishment Name Address ID/FEI Business Operations Allied Pressroom Products 069895618 manufacture(78851-333)