FDA Label for Papilion Hygienic Disinfectant Antibacterial
View Indications, Usage & Precautions
Papilion Hygienic Disinfectant Antibacterial Product Label
The following document was submitted to the FDA by the labeler of this product Ar Kagit San. Ve Tic. Ltd. Sti.. 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) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, 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 (0.5% v/v).
- Aloe Vera Leaf (0.1% v/v).
- Sterile distilled 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: Antibacterial
Purpose
Antibacterial, Papilion Hygienic Disinfactant Antibacterial Sprey
Uses
Use disinfectant spray to help reduce bacteria on the skin that could cause disease.
Warnings
For external use only. Flammable. Keep away from fire or flame.
Otc - When Using
When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness devolops 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
- Put enough product in your palm to cover hands and rub hands together until dry.
- Children under 6 years should be supervised when using this product.
Other Information
- Store below 106 F (41 C).
- May discolor certain fabrics or surfaces.
Inactive Ingredients
Water (Aqua), Glycerin, Propylene Glycol, Aloe Barbadensis Extract.
Recent Major Changes
120 ml NDC: 79262-160-01
Package Label - Principal Display Panel
120 mL NDC: 79262-160-01
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