BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL- alcohol swab

biom Sanitizing Alcohol Wipes - Eucalyptus Chill by

Drug Labeling and Warnings

biom Sanitizing Alcohol Wipes - Eucalyptus Chill by is a Otc medication manufactured, distributed, or labeled by Biom Innovations Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

Alcohol 65% w/w. Purpose: Antiseptic

Purpose

Reducing bacteria on skin.

Directions

Wipe hands thoroughly. Discard after use.

Dosage and Administration

Ethanol 65%. Wipe hands thoroughly. Discard after use.

Warnings

Flammable. Keep away from Fire. 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.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact the poison control center immediately.

Other information

Store below 104° F (40° C).
Each wipe is 4.5" x 7".
May discolor certain fabrics.
Do not use as a baby wipe, on the face, or in the genital area.

Inactive ingredients

Water, Eucalyptus Globulus Leaf Oil (Eucalyptus Essential Oil), Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)

Package Label - Principal Display Panel

40 wipes; NDC82311-0101-3

INGREDIENTS AND APPEARANCE

BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL 
alcohol swab

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: 82311-0101-3	144 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/11/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/11/2024

Labeler - Biom Innovations Inc (118335373)