DEEP FRESH ANTISEPTIC ALCOHOL WIPES- alcohol cloth 
AKSAN KOZMETIK 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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Deep Fresh Antiseptic Alcohol 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. 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. DICAPRYLYL CARBONATE (0.01 % v/v).
  3. OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (0.1 % v/v).
  4. POLYSORBATE 20 (0.2 % v/v).
  5. GLYCERYL OLEATE (0.01 % v/v).
  6. LAURYL GLUCOSIDE (0.1 % v/v).
  7. FATTY-ACID AMIDE HYDROLASE(0.1 % v/v).
  8. GLYCERIN (0.5 % v/v).
  9. PANTHENOL (0.1 % v/v).
  10. 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

Antiseptic/Antiviral, Hand Sanitizer

Use

Hand Sanitizer wet wipes to help 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

  • in children less than 2 months of age
  • on open skin wounds

When using In case of swallowing, rinse mouth with plenty of water. Get medical advise. In case of contact with eyes, If you are wearing contact lenses, remove them immediately. Rinse your eyes with plenty of clean water. Get medical attention if symptoms persist.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

  • Open the cap and get enough wipes from inside. Wipe your hands gently with the wipes.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Dicaprylyl Carbonate, Glycerin, Glyceryl Oleate, Lauryl Glucoside, Olus Oil, Panthenol, Parfum, Polyglyceryl-2 Dipolyhydroxystearate, Polysorbate 20, Water

Package Label - Principal Display Panel

160 pcs

100 pcs

56 pcs

80 pcs

500 pcs

15 pcs

DEEP FRESH ANTISEPTIC ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-008
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
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) 0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
PANTHENOL (UNII: WV9CM0O67Z) 0.1 mL  in 100 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 mL  in 100 mL
OCTADECANOIC ACID, (OCTADECYLIMINO)DI-2,1-ETHANEDIYL ESTER (UNII: X0S2P50TYC) 0.1 mL  in 100 mL
GLYCERYL OLEATE (UNII: 4PC054V79P) 0.01 mL  in 100 mL
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) 0.1 mL  in 100 mL
FATTY-ACID AMIDE HYDROLASE 1 (UNII: E747F394ZQ) 0.1 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86815-008-0215 in 1 PACKAGE03/30/2020
1NDC:86815-008-011.8 mL in 1 PATCH; Type 0: Not a Combination Product
2NDC:86815-008-0456 in 1 PACKAGE03/30/2020
2NDC:86815-008-032.916 mL in 1 PATCH; Type 0: Not a Combination Product
3NDC:86815-008-0680 in 1 CANISTER03/30/2020
3NDC:86815-008-054.374 mL in 1 PATCH; Type 0: Not a Combination Product
4NDC:86815-008-08500 in 1 CANISTER03/30/2020
4NDC:86815-008-074.374 mL in 1 PATCH; Type 0: Not a Combination Product
5NDC:86815-008-11100 in 1 CANISTER03/30/2020
5NDC:86815-008-104.374 mL in 1 PATCH; Type 0: Not a Combination Product
6NDC:86815-008-13160 in 1 CANISTER03/30/2020
6NDC:86815-008-124.374 mL in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
Registrant - AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (365577706)
Establishment
NameAddressID/FEIBusiness Operations
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI365577706manufacture(86815-008)

Revised: 1/2021
Document Id: b89fa11f-735d-ba6b-e053-2a95a90a3b5b
Set id: aae503bc-b6d2-9fc0-e053-2995a90a40d7
Version: 7
Effective Time: 20210111
 
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI