Label: B FREE- ethyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated November 22, 2021

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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

    • 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: 77418-100-01

    500

    100 mL NDC: 77418-100-02

    100ml

    1 L NDC: 77418-100-03

    1l

    50 mL NDC: 77418-100-04

    50

    20 mL NDC: 77418-100-05

    20

    3.79 L NDC: 77418-100-06

    1gl

    100 mL NDC: 77418-100-07

    100

  • INGREDIENTS AND APPEARANCE
    B FREE 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77418-100
    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 934 (UNII: Z135WT9208)  
    ASCORBYL TOCOPHERYL MALEATE (UNII: D2G6259XR5)  
    ALOE (UNII: V5VD430YW9)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHANOLAMINE HYDRIODIDE (UNII: DT98IT03JK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77418-100-01500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    2NDC:77418-100-02100 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    3NDC:77418-100-031000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    4NDC:77418-100-0450 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    5NDC:77418-100-0520 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    6NDC:77418-100-063790 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/31/2020
    7NDC:77418-100-07100 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 finalpart333A03/30/2020
    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(77418-100)
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