Label: DOP ISOPROPYL RUBBING ALCOHOL 70%- isopropyl alcohol liquid

  • NDC Code(s): 51048-005-16, 51048-005-32
  • Packager: Omega & Delta Co., Inc.
  • 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 November 12, 2020

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  • Drug Facts

  • Active ingredient

    Isopropyl alcohol 70%

  • Purpose

    First aid antiseptic

  • 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.

  • INDICATIONS & USAGE

    Use helps prevent the risk of infection in minor cuts, scrapes and burns

  • WARNINGS

    Warnings  For external use only

    Flammable keep away from fire or flame, heat, spark, electrical

    Ask a doctor before use for deep wounds, animal bites or serious burns

    When using this product • do not get into eyes • do not apply over large area of the body • do not use longer than 1 week

    Stop use and ask a doctor if the condition persists or gets worse

  • DOSAGE & ADMINISTRATION

    Directions • clean the affected area • apply 1 to 3 times daily

  • INACTIVE INGREDIENT

    Inactive ingredient Purified water

  • OTHER SAFETY INFORMATION

    Other information • does not contain, nor is intended as a substitute for grain or ethyl alcohol • will produce serious gastric disturbances if taken internally

  • SPL UNCLASSIFIED SECTION

    Manufactured by:

    Omega & Delta Co., Inc.

    Carolina, P.R. 00984

  • PRINCIPAL DISPLAY PANEL

    isopropyl alcohol 1

  • INGREDIENTS AND APPEARANCE
    DOP ISOPROPYL RUBBING ALCOHOL 70% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51048-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51048-005-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2000
    2NDC:51048-005-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2000
    Labeler - Omega & Delta Co., Inc. (090317793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega & Delta Co., Inc.090317793manufacture(51048-005)
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