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

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)

Alcohol 65% w/w. Purpose: Antiseptic

Purpose

Reducing bacteria on skin.

Directions

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.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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)

Keep out of reach of children

If swallowed, get medical help or contact the poison control center immediately.

Dosage and Administration

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


Package Label - Principal Display Panel

50 wipes; NDC: 82311-0101-1

BIOM01 Eucalyptus Chill - sanitising alcohol wipes

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:82311-0101-1263 mL in 1 PACKAGE; Type 0: Not a Combination Product12/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/04/2021
Labeler - Biom Innovations Inc (118335373)

Revised: 10/2021
Document Id: cd27de46-8fc7-a429-e053-2995a90a6ec8
Set id: cd27de46-8fd5-a429-e053-2995a90a6ec8
Version: 1
Effective Time: 20211024
 
Biom Innovations Inc