Label: MODAKA ALCOHOL HAND SANITIZER- 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 May 15, 2020

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  • Drug Facts

  • Active Ingredient (s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Anti-Bacterial, Anti-microbial and Germs

  • INDICATIONS & USAGE

    Use(s) for hand-washing to decrease bacteria on the skin, only when water is not available

  • Warnings

    Flammable, keep away from fire and flames

    For external use only

    When using this product

    - do not get into eyes

    - if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    - irritation and redness develop

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

  • DOSAGE & ADMINISTRATION

    Direction No water required. Apply to hands, rub in, ensuring contact with fingernails and in between fingers. Can also be applied to the body.

  • INACTIVE INGREDIENT

    Inactive Ingredients water, Propylene Glycol, Trehalose, Sodium Benzoate, Potasssium Sorbate, Dendrobium Bigibbum (Orchid) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Fragrance, Allantoin.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    MODAKA  ALCOHOL HAND SANITIZER
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77779-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL750 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DENDROBIUM BIGIBBUM FLOWER (UNII: Q7KU1V305F)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77779-001-0160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/15/2020
    2NDC:77779-001-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2020
    Labeler - WE LABS COMPANY LIMITED (671868760)
    Establishment
    NameAddressID/FEIBusiness Operations
    WE LABS COMPANY LIMITED671868760manufacture(77779-001)
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