Label: BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL- alcohol swab
- NDC Code(s): 82311-0101-1
- Packager: Biom Innovations 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.
Updated October 24, 2021
If you are a consumer or patient please visit this version.
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) (65%, volume/volume (w/w)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Active Ingredient(s)
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.
- STOP USE
- Other information
- Inactive ingredients
- Keep out of reach of children
- Dosage and Administration
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL
Product 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:82311-0101-1 263 mL in 1 PACKAGE; Type 0: Not a Combination Product 12/31/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/04/2021 Labeler - Biom Innovations Inc (118335373)