BIOM SANITIZING ALCOHOL WIPES - TEA TREE BLISS- alcohol swab

biom Sanitizing Alcohol Wipes - Tea Tree Bliss by

Drug Labeling and Warnings

biom Sanitizing Alcohol Wipes - Tea Tree Bliss 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This is a hand sanitizer manufactured in compliance with (the now withdrawn) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.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%, (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.

Keep out of reach of children

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

STOP USE

Stop use and ask a doctor if redness or irritation develops and continues for more than 72 hours.

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, Tea Tree Oil, Aloe Barbadensis Leaf Juice (Organic Aloe), Glycerin (Moisturizer)

Dosage and Administration

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

Package Label - Principal Display Panel

50 wipes; NDC: 82311-0118-1, Hand Sanitizing Tea Tree Bliss

INGREDIENTS AND APPEARANCE

BIOM SANITIZING ALCOHOL WIPES - TEA TREE BLISS 
alcohol swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82311-0118
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)	2.63 mL  in 263 mL
TEA TREE OIL (UNII: VIF565UC2G)	0.1315 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: 82311-0118-1	263 mL in 1 PACKAGE; Type 0: Not a Combination Product	10/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/18/2023

Labeler - Biom Innovations Inc (118335373)