FDA Label for Biom Sanitizing Alcohol Wipes - Bergamot Bloom
View Indications, Usage & Precautions
Biom Sanitizing Alcohol Wipes - Bergamot Bloom 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 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.
Otc - Stop Use
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, Citrus Bergamia Peel Oil (Bergamot 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: 82311-0102-1
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