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 Hs Homeworx Llc. 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 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic
Use
to help reduce bacteria on skin.
Warnings
Flammable. Keep away from fire, high heat or flame. For external use only.
Otc - When Using
When using this product, avoid contact with eyes. If contact occurs, rinse 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 occurs.
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
- Dispense into hands, Rub thoroughly until dry.
Other Information
- May discolor certain fabrics or surfaces.
- Do not store above 110 F (43 C)
Inactive Ingredients
Aqua (Water), Glycerin, Butylene Glycol, Fragrance (Parfum), Aloe Barbadensis Leaf Extract, Artemisia Argyi Leaf Extract, Cnidium Monnieri Fruit Extract, Sargassum Fusiforme Extract
Package Label - Principal Display Panel
56 mL NDC: 81282-042-01
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