Label: FASHION ANTISEPTIC GEL HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 December 28, 2020

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  • Drug Facts Panel - Active Ingredients

    Denatured Ethyl Alcohol 70%. Purpose: Antiseptic

  • Drug Facts Panel - Purpose

    Purpose: Antiseptic.

  • Drug Facts Panel - Uses

    Use: Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Drug Facts Panel - 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.

    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.

    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.

  • Drug Facts Panel - Directions

    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.

  • Drug Facts Panel - Other Information

    Other information:
    ● Store between 15-30 °C (59-86 °F)
    ● Avoid freezing and excessive heat above 40 °C (104 °F)

  • Drug Facts Panel - Inactive Ingredients

    Inactive ingredients:
    Aminomethyl Propanol, Carbomer, Glycerin, Water.

  • Drug Facts Panel - Question and reporting of adverse events

    Questions or reporting of adverse events?
    Contact weekdays from 9AM to 5PM at 1-786-272-5677

  • DOSAGE & ADMINISTRATION

  • Package Label - Principal Display Panel

    60 ml NDC 78904-001-01

    Label 60 ml

    200 ml NDC 78904-001-02

    200 ml Label

    400 ml NDC 78904-001-03

    Label 400 ml

    500 ml NDC 78904-001-04

    Label 500 ml

    1000 ml NDC 78904-001-05

    Label 1000 ml

    5000 ml NDC 78904-001-06

    Label 5000 ml

    5 ml NDC 78904-001-07

    Level 1

    Label 5 ml

    50x5 ml NDC 78904-001-07

    Level 2

    Label 50x5 ml

  • INGREDIENTS AND APPEARANCE
    FASHION ANTISEPTIC GEL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78904-001
    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
    WATER (UNII: 059QF0KO0R) 26.35 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 3 mL  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.3 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.35 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78904-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    2NDC:78904-001-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    3NDC:78904-001-03400 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    4NDC:78904-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    5NDC:78904-001-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2020
    6NDC:78904-001-065000 mL in 1 JUG; Type 0: Not a Combination Product07/14/2020
    7NDC:78904-001-0750 in 1 CARTON07/14/2020
    75 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2020
    Labeler - JOAO HENRIQUE SILVA BESSA E CIA LTDA (899478850)
    Establishment
    NameAddressID/FEIBusiness Operations
    JOAO HENRIQUE SILVA BESSA E CIA LTDA899478850manufacture(78904-001) , pack(78904-001) , label(78904-001)
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