Label: HAND SANITIZER ALCOHOL ANTISEPTIC 70% TOPICAL GEL -MV- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71158-005-01, 71158-005-02, 71158-005-03, 71158-005-04, view more71158-005-05, 71158-005-09 - Packager: Solugen, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 September 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the part333A of the OTC monograph.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
formulation)
a. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v) in an aqueos solution denatured according to Alcohol and Tobacco
Bureau regulations in 27 CFR part 20.
b. Glycerol (1.25% v/v).
c. Hydroxymethyl Cellulose (1.05% v/v) .
d. Sterile distilled water or boiled cold water. - 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
- Hand Sanitizer Alcohol Antiseptic 70% Topical Gel - MV
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INGREDIENTS AND APPEARANCE
HAND SANITIZER ALCOHOL ANTISEPTIC 70% TOPICAL GEL -MV
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71158-005 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 GLYCERIN (UNII: PDC6A3C0OX) 1.25 mL in 100 mL WATER (UNII: 059QF0KO0R) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) 1.05 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71158-005-01 18927000 mL in 1 TANK; Type 0: Not a Combination Product 08/31/2020 2 NDC:71158-005-02 1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 08/31/2020 3 NDC:71158-005-03 208198 mL in 1 DRUM; Type 0: Not a Combination Product 08/31/2020 4 NDC:71158-005-04 18927 mL in 1 DRUM; Type 0: Not a Combination Product 08/31/2020 5 NDC:71158-005-05 3785 mL in 1 PAIL; Type 0: Not a Combination Product 08/31/2020 6 NDC:71158-005-09 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/31/2020 Labeler - Solugen, Inc. (057475094) Establishment Name Address ID/FEI Business Operations Solugen, Inc. 057475094 manufacture(71158-005) Establishment Name Address ID/FEI Business Operations Solugen, Inc. 117507685 manufacture(71158-005)