ART NATURALS- hand sanitizing wipes, ethanol cloth 
SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI

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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HAND SANITIZING WIPES

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. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% 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)

Ethanol 75% Purpose: Antiseptic

Purpose

Antiseptic

Use

Single use wipes to reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

These wipes do not replace wipes used for medical procedures

If eye contact occurs flush eyes with water

Stop use if irritation and redness develop. If condition continues, consult your health care practitioner

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Unfold towelette, wipe hands, discard after use

Other information

Inactive ingredients

Water

Package Label - Principal Display Panel

50 pcs

200 gr NDC: 81406-002-50

Art Naturals 50 pcs

Hand Sanitizing Wipes- 50 pcs
NDC: 81406-002-50

Hand Sanitizing Wipes- 50 pcs-200 gr

NDC: 81406-002-50

Hand Sanitizing 50 pcs

ART NATURALS 
hand sanitizing wipes, ethanol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81406-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 25 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81406-002-50200 g in 1 POUCH; Type 0: Not a Combination Product02/15/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/15/2021
Labeler - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)
Registrant - SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI (366438166)
Establishment
NameAddressID/FEIBusiness Operations
SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI366438166manufacture(81406-002)

Revised: 10/2021
Document Id: cf36ec22-8211-7358-e053-2a95a90a3ffe
Set id: ba7179f9-cbf7-18e8-e053-2995a90a28ae
Version: 2
Effective Time: 20211025
 
SEPA MENSUCAT SANAYI VE TICARET ANONIM SIRKETI