FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Trang Ly Pharma Trade Company Limited. 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 80% v/v. Purpose: Antiseptic
Purpose
Antimicrobial
Use
Dry Hand Sanitizer helps prevent the development of bacteria on the skin.
It moisturizes and softens the hand skin with the sweet fragrance.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- for children under 36 months.
Otc - When Using
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
For children: need to be supervised by adults when using it.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
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.
Other Information
- Store in dry and cool place
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Recent Major Changes
Update Uses: from template to label description.
Otc - Keep Out Of Reach Of Children
Keep our of reach of children
Package Label - Principal Display Panel
100 mL NDC: 90098-100-01
250 mL NDC: 90098-100-02
500 mL NDC: 90098-100-03
1000 mL NDC: 90098-100-04
2000 mL NDC: 90098-100-05
10000 mL NDC: 90098-100-06
20000 mL NDC: 90098-100-07
59 mL NDC: 90098-100-08
1 Gallon NDC: 90098-100-09
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