B FREE GEL- ethyl alcohol gel 
ATAK FARMA KOZMETIK VE KIMYA SANAYI 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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Active Ingredient(s)

Ethyl 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

water,glycerin,tocopheryl acetate, Aloe , Fragrance

Package Label - Principal Display Panel

500 mL NDC: 77418-200-01

500

1 L NDC: 77418-200-04

1l

3.79 L NDC: 77418-100-02

1gl

100 mL NDC: 77418-200-03

100

B FREE GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-200
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
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
ALOE (UNII: V5VD430YW9)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77418-200-01500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
2NDC:77418-200-023790 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
3NDC:77418-200-03100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
4NDC:77418-200-041000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/31/2020
Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Registrant - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)
Establishment
NameAddressID/FEIBusiness Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI566218248manufacture(77418-200)

Revised: 1/2021
Document Id: b8ba3303-9ba8-092a-e053-2995a90aa234
Set id: b815146f-65ac-6e92-e053-2995a90a7c2e
Version: 2
Effective Time: 20210112
 
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI