FDA Label for Biom Sanitizing Alcohol Wipes - Tea Tree Bliss
View Indications, Usage & Precautions
Biom Sanitizing Alcohol Wipes - Tea Tree Bliss Product Label
The following document was submitted to the FDA by the labeler of this product Biom Innovations Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a hand sanitizer manufactured in compliance with (the now withdrawn) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.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.
Otc - 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
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