FDA Label for Instant Hand Sanitizer 70% Alcohol
View Indications, Usage & Precautions
Instant Hand Sanitizer 70% Alcohol Product Label
The following document was submitted to the FDA by the labeler of this product Davemed Healthcare Co., Ltd. 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) (80%, 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).
- Hydrogen peroxide (0.125% 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 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin. Recommended for repeated use
Warnings
Flammable.
Keep away from fire or flame
For external use only
When using this product
- avoid contact with eyes
- in case of eye contact, immediately flush eyes with water, call a doctor
- avoid contact with broken skin
Discontinue use if irrittion or redness develops. If condition persists for more than 72 hours, consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Children should only use this product under adult supervision
Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. Recommended for repeated use
Other Information
- Do not store above 105F
- May discolor some fabrics.
- Harmful to wood finishes and plastics
Inactive Ingredients
aloe bardensis leaf extract, caprylyl glycol carbomer, glycerin, isopropyl alcohol, isopropyl myristate, hydrochloric acid, sodium chloride
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