FDA Label for Pyurx
View Indications, Usage & Precautions
Pyurx Product Label
The following document was submitted to the FDA by the labeler of this product Novara 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.
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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:
Isopropyl Alcohol (75%, 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.
SEE INGREDIENTS LIST FOR ACCURATE LIST
Active Ingredient(S)
Ethyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
- For hand washing to decrease bacteria on the skin.
- Recommended for repeated use.
Warnings
- For external use only.
- Flammable, keep away from heart and flame.
Do Not Use
- Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.
- Do not use on children less than 2 months of age.
Otc - Stop Use
Stop use and ask a doctor if
- Irritaion, and redness develop and persist for more than 72 hours.
- Swallowed, get medical help or contact a poison control center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Children must be supervised in use of this product.
Directions
- Place enough product in your palm to cover hands and rub hands together 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
Aqua(water), Glycerin, Carbomer, Triethanolamine, Aloe, Tocopheryl Acetate (Vitamin E).
Package Label - Principal Display Panel
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