PAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER- alcohol gel 
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.

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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) 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. Carbomer 940 (0.33% v/v).
  5. Triethanolamin (0.2% v/v).
  6. 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: Antiseptic

Purpose

Antiseptic, Papilion Hygienic Antibacterial Hand Sanitizer

Uses

Uses hand sanitizer 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

Other information

Inactive ingredients

Water (Aqua), Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Juice, Triethanolamine.

Package Label - Principal Display Panel

500 mL NDC: 79262-110-02 500 ml500 ml text

PAPILION HYGIENIC ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79262-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.33 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.1 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.2 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.25 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79262-110-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/30/2020
Labeler - AR KAGIT SAN. ve TIC. LTD. STI. (356385935)

Revised: 2/2021
Document Id: bc65ef4b-cd4e-79d4-e053-2995a90a63b4
Set id: b098d9b5-9f6d-2ea8-e053-2a95a90a7aef
Version: 4
Effective Time: 20210228
 
AR KAGIT SAN. ve TIC. LTD. STI.