FDA Label for Instant Hand Sanitizer
View Indications, Usage & Precautions
Instant Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Dongyang Medical & Hygienic Articles 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
- to decrease bacteria on the skin that could cause disease.
- recommended for repeated use.
Warnings
- For external use only. Flammable.
- Keep away from heat or flame.
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product:
- keep out of eyes. In case of contact with eyes, flush thoroughly with water.
- avoid contact with broken skin
- do not inhale or ingest.
Otc - Stop Use
Stop use and ask a doctor:
- if irritation or redness develops.
- condition persists for more than 72 hours.
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
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Inactive Ingredients
purified water,Propylene Glycol,Glycerin, CARBOMER, AMINOMETHYL PROPANOL
Package Label - Principal Display Panel
350 mL NDC: 81276-008-01
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