FDA Label for American Beauty Advanced Hand Sanitizer
View Indications, Usage & Precautions
American Beauty Advanced Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product American Beauty Manufacturing 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
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)
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydroxypropyl Cellulose (1.00% w/w).
- Aplha-Tocopherol Acetate (0.05% w/w).
- Isopropyl Myristate (0.50% v/v)
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 65% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
Recommended for repeated use
Warnings
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes.
In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin.
Stop use and ask a doctor if irritation or redness develop.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product in your palm to thoroughly cover your hands
- Rub hands together until dry
- No rinsing or towels required
Inactive Ingredients
water, glycerin, hydroxypropylcellulos, isopropyl myristate, tocopheryl acetate
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Questions
Call 918-516-8340 Monday to Friday 8:00am to 5:00pm CST
Other Safety Information
Do not store above 110*F (43*C)
May discolor certain fabrics or surfaces
Package Label - Principal Display Panel
3.78L NDC: 76907-401-01
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