OTC Medication Information: B Free Gel

B FREE GEL- 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.

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 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

  • 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

500
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1 L NDC: 77418-200-04

1l
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3.79 L NDC: 77418-100-02

1gl
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100 mL NDC: 77418-200-03

100
(click image for full-size original)
B FREE GEL
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:77418-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBYL TOCOPHERYL MALEATE
ALOE
FRAGRANCE CLEAN ORC0600327
GLYCERIN
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:77418-200-01 500 mL in 1 BOTTLE, DISPENSING None
2 NDC:77418-200-02 3790 mL in 1 BOTTLE, DISPENSING None
3 NDC:77418-200-03 100 mL in 1 BOTTLE, DISPENSING None
4 NDC:77418-200-04 1000 mL in 1 BOTTLE, DISPENSING None
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 Operations
ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI 566218248 manufacture (77418-200)

Revised: 01/2021 ATAK FARMA KOZMETIK VE KIMYA SANAYI TICARET ANONIM SIRKETI

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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