OTC Medication Information: PAPILION HYGIENIC DISINFECTANT ANTIBACTERIAL

PAPILION HYGIENIC DISINFECTANT ANTIBACTERIAL- alcohol liquid
AR KAGIT SAN. ve TIC. LTD. STI.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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:

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. Glycerol (0.5% v/v).
3. Aloe Vera Leaf (0.1% v/v).
4. 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.

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.

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.

Stop use and ask a doctor if irritation or redness devolops and lasts.

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.

Package Label — Principal Display Panel

120 mL NDC: 79262-160-01

PAPILION HYGIENIC DISINFECTANT ANTIBACTERIAL alcohol liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79262-160 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN 0.5 mL in 100 mL WATER ALOE VERA LEAF 0.1 mL in 100 mL PROPYLENE GLYCOL 0.25 mL in 100 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79262-160-01 120 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/21/2021

Labeler — AR KAGIT SAN. ve TIC. LTD. STI. (356385935)

Revised: 02/2021 AR KAGIT SAN. ve TIC. LTD. STI.