Label: 2OZ ALCOHOL solution

  • 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 October 16, 2020

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  • DOSAGE & ADMINISTRATION

    Dosage

  • INACTIVE INGREDIENT

    Inactive

  • ACTIVE INGREDIENT

    Active

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach

  • PURPOSE

    Purpose

  • WARNINGS

    Warnings

  • INDICATIONS & USAGE

    Indications and Usage

  • PRINCIPAL DISPLAY PANEL

    PDP

  • INGREDIENTS AND APPEARANCE
    2OZ ALCOHOL 
    2oz alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90055-212
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 70 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90055-212-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/16/2020
    Labeler - Collective Science Integration (133591508)
    Establishment
    NameAddressID/FEIBusiness Operations
    P&P International133591508manufacture(90055-212)