Label: ISOPROPYL RUBBING ALCOHOL 70 PERCENT- isopropyl 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 June 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% by volume

  • Purpose

    First aid antiseptic

  • Use

    First aid to help prevent the risk of infection in.

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    • Flammable, keep way from spark, heat and flame.
  • Ask a doctor before use for

    • deep wounds
    • animal bites
    • serious burns
  • When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area.
    • apply a small amount of this product on the affected area 1 to 3 times daily.
    • may be covered with sterile bandage.
    • if bandaged, let it dry first.
  • Other Information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol.
    • will produce serious gastric disturbances if taken internally.
  • Inactive Ingredient

    purified water

  • Good Neighbor Label

    Principal Display Panel NDC 46122-330-43 ISOPROPYL RUBBING ALCOHOL 70% USP First Aid Antiseptic 16 fl oz (1 pt) 473 mL

  • Health Mart Label

    HM70.jpgHM

  • Sunmark Label

    SM70.jpgSM

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 70 PERCENT 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9120-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    2NDC:0395-9120-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    3NDC:0395-9120-283800 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9120) , analysis(0395-9120) , pack(0395-9120) , label(0395-9120)
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