HAND SANITIZER- alcohol gel 
AKKIM YAPI KIMYASALLARI 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.

----------

Akkim Hand Sanitizer Gel-100, 250, 500, 1000, 5000 ml

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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.

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

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water, triethanolamine, carbomer, fragrance

Package Label - Principal Display Panel 100 ml

Akfix Hand Sanitizer Gel 100

Package Label, Principal Display Panel 250 ml

Akfix Hand Sanitizer Gel 250

Package Label, Principal Display Panel 500

Akfix Hand Sanitizer Gel 500

Package Label, Principal Display Panel 1000 ml

Akfix Hand Sanitizer Liquid Gel 1000

Package Label, Principal Display Panel 5000 ml

Akfix Hand Sanitizer Gel 5000

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79886-002
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 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79886-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
2NDC:79886-002-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
3NDC:79886-002-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
4NDC:79886-002-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
5NDC:79886-002-505000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/20/2020
Labeler - AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI (366467348)
Establishment
NameAddressID/FEIBusiness Operations
AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI366467348manufacture(79886-002) , pack(79886-002) , label(79886-002)

Revised: 12/2021
Document Id: d4579684-7dab-7b87-e053-2995a90aae0e
Set id: ad0b2235-b9f7-3740-e053-2995a90afd8c
Version: 2
Effective Time: 20211230
 
AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI