FDA Label for Hand Sanitizerportcall
View Indications, Usage & Precautions
Hand Sanitizerportcall Product Label
The following document was submitted to the FDA by the labeler of this product Genesis Salon Products 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) (70%) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol
- Sterile distilled water.
Active Ingredient(S)
Alcohol 70%. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from fire and flame
Do Not Use
- Do not use in or near eyes.
Otc - When Using
When using this product do not use in or ner eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Put enough product in your palm to cover hands and rub together briskly until dry.
Children under 6 years of age should be supervised when using this product
Other Information
- Store below 110F (43C).
- May discolor certain fabrics or surfaces.
Inactive Ingredients
Deionized water, glycerin, polysorbate 20, aloe barbadensis leaf juice, citrus aurantium dulcis peel oil, tocopheryl acetate, maltodextrin, parfum
Package Label - Principal Display Panel
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