BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL- alcohol swab 
Biom Innovations Inc

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.

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Sanitizing Alcohol Wipes - Eucalyptus Chill - 10 wipes

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 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.

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 15 x 20 cm.
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

10 wipes; NDC82311-0101-2 10 wipes; NDC82311-0101-2

BIOM SANITIZING ALCOHOL WIPES - EUCALYPTUS CHILL 
alcohol swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82311-0101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL184.1 mL  in 263 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82311-0101-242 mL in 1 PACKAGE; Type 0: Not a Combination Product02/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/25/2022
Labeler - Biom Innovations Inc (118335373)

Revised: 1/2023
Document Id: f15a23ba-0b04-8969-e053-2a95a90a84d7
Set id: d911fa72-3dc1-2d86-e053-2995a90aeb9c
Version: 2
Effective Time: 20230103
 
Biom Innovations Inc