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 Sun Hing Foods 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
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)
Ethyl Alcohol 70%, Isopropyl Alcohol 0.5%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from fire or flame
Do Not Use
- Children under 6 years of age should be supervised when using LORO
When Using This Product
do not use in or near eyes. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop Use And Ask A Doctor If:
irritation or rash appears and lasts.
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.
Other Information
- Store below 111 Degree F (43 Degree C)
- May discolor certain fabrics or surfaces
Manufacture By:
Hanoi Biology Chemistry Group Corporation
252/57 Tay Son, Trung Liet Ward, Dong Da District
Hanoi, Vietnam
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP
Package Label - Principal Display Panel
5000 mL NDC: 78185-004-01
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