DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL- alcohol gel 
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 ANTIBACTERIAL HAND SANITIZER GEL

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) 70%, 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. Carbomer (0.35% v/v).
  4. Triethanolamine (0.1% v/v).
  5. 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 70% v/v. Purpose: Antibacterial

Purpose

Antibacterial Hand Gel

Use

Hand Sanitizer 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 fire,flame,sparks and heat. Keep away from children, food and animal feeds.

Do not use

Do not inhale the vapour or grains of the product if occurs. In case of inhaling: If you feel uncomfortable get some fresh air.In case of contact with eyes:If you are wearing contact lenses, remove them immediately.Rinse your eyes with plenty of clean water. Seek for medical advice if necessary. In case of swallowing: Rinse the patient's mouth with water and drink water. Keep it calm. Do not induce vomiting. Call your local Toxication Center and get medical help.

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

Take some Antibacterial gel in your hand. Rub your hands, between the fingers, all the inner and outer surfaces, the nails, until they dry. It is used for hand cleaning. Do not rinse after use.

Other information

Inactive ingredients

glycerin, Carbomer, purified water USP, Triethanolamine

Package Label - Principal Display Panel

1000 mL NDC: 86815-002-04

1000 ML

2500 mL NDC: 86815-002-05

2500 ML

500 mL NDC: 86815-002-01

500 ML

100 mL NDC: 86815-002-02

100 ML

200 mL NDC: 86815-002-03

200 ML

DEEP FRESH ANTIBACTERIAL HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86815-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 1342 (UNII: 809Y72KV36) 0.35 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.05 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86815-002-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
2NDC:86815-002-052500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
3NDC:86815-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
4NDC:86815-002-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
5NDC:86815-002-03200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
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(86815-002)

Revised: 1/2022
Document Id: d64741db-01c4-3382-e053-2a95a90a4648
Set id: a78faa3a-466e-81b6-e053-2995a90a3233
Version: 9
Effective Time: 20220123
 
AKSAN KOZMETIK SANAYI VE TICARET ANONIM SIRKETI