FDA Label for Papilion Hygienic Alcohol Wipes Antibacterial
View Indications, Usage & Precautions
Papilion Hygienic Alcohol Wipes 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.
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Papilion HYGIENIC ALCOHOL WIPES
ANTIBACTERIAL
EXTA PROTECTION AND CLEANING
REDUCE 99% OF GERMS & BACTERIA
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:
1. 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.
2. ALOE BARBADENSIS EXTRCT (0.1 % v/v).
3. GLYCERIN (0.5 % v/v).
4. 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/ Antiviral
Purpose
Papilion HYGIENIC ALCOHOL WIPES
ANTIBACTERIAL
Uses
Alcohol wipes to help reduce bacteria that potentially can cause disease.
Warnings
For external use only.
Do not use
in children less than 2 months of age
On open skin wounds
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
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
Open package, remove one wet wipe to clean your hands and body. Reseal, keep closed to prevent evaporation.
Allow to dry without wiping. Discard propearly after use.
Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store at room temperature
Do not flush down toilet.
Inactive Ingredients
Water, Glycerin, Aloe barbadensis Extract.
Package Label - Principal Display Panel
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