Label: BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL- alcohol swab
- NDC Code(s): 82311-0101-2
- Packager: Biom Innovations Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 7, 2024
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- Official Label (Printer Friendly)
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SPL UNCLASSIFIED SECTION
This hand sanitizer (65%(w/w) ethanol in an aqueous solution):
- Is manufactured using United States Pharmacopoeia (USP) grade ingredients.
- The alcohol (ethanol) is (USP or Food Chemical Codex (FCC) grade), and is denatured according to Alcohol & Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Active Ingredient(s)
- Purpose
- Directions
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Warnings
Flammable. Keep away from Fire and Flame. External Use Only. Do not use in eyes. If contact occurs, flush thoroughly with water. Stop use and ask doctor if redness or irritation develops and continues for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL
alcohol swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82311-0101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 184.1 mL in 263 mL Inactive Ingredients Ingredient Name Strength EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) 0.1315 mL in 263 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 2.63 mL in 263 mL GLYCERIN (UNII: PDC6A3C0OX) 2.64315 mL in 263 mL WATER (UNII: 059QF0KO0R) 73.49535 mL in 263 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82311-0101-2 42 mL in 1 PACKAGE; Type 0: Not a Combination Product 02/25/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/25/2022 Labeler - Biom Innovations Inc (118335373)