B FREE GEL- ethyl alcohol gel

b free gel by

Drug Labeling and Warnings

b free gel by is a Otc medication manufactured, distributed, or labeled by ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

WHEN USING

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

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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• 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

water,glycerin,tocopheryl acetate, Aloe , Fragrance

Package Label - Principal Display Panel

500 mL NDC: 77418-200-01

1 L NDC: 77418-200-04

3.79 L NDC: 77418-100-02

100 mL NDC: 77418-200-03

INGREDIENTS AND APPEARANCE

B FREE GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77418-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)
ALOE (UNII: V5VD430YW9)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77418-200-01	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/31/2020
2	NDC: 77418-200-02	3790 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/31/2020
3	NDC: 77418-200-03	100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/31/2020
4	NDC: 77418-200-04	1000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/31/2020

Labeler - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)

Registrant - ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI (566218248)

Establishment
Name	Address	ID/FEI	Business Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI		566218248	manufacture(77418-200)