FDA Label for Disinfectant Alcohol
View Indications, Usage & Precautions
Disinfectant Alcohol Product Label
The following document was submitted to the FDA by the labeler of this product Jiangsu Doer Biotechnology 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, DISINFECTANT ALCOHOL
Use
fist aid to help prevent prevent the risk of infection in minor cuts, scrapes, and burms.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
- do not get into eyes.
- do not apply over large areas of the body.
- do not use longer than one week unless directed by a doctor.
Otc - Stop Use
Stop use and ask a doctor if condition persists or gets worse.
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.
Directions
- dean affected area
- apply small amount of this product on the area 1-3 times daily
- if bandaged, let dry first
- may be covered with a sterile bandage
Other Information
- store at room temperature
- does not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
NDC: 55449-005
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