ISOPROPYL ALCOHOL LIQUID [HYDROX LABORATORIES]

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ISOPROPYL ALCOHOL LIQUID [HYDROX LABORATORIES]
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NDC 10565-071-16, 10565-071-32
Set ID f2f07464-6bd5-434c-8dea-0ba659c0e549
Category HUMAN OTC DRUG LABEL
Packager Hydrox Laboratories
Generic Name
Product Class
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Isopropyl alcohol 91%

  • Purpose

    First Aid Antiseptic

  • Uses

    • first aid to help prevent the risk of infection in:
      • minor cuts
      • scrapes
      • burns
  • Warnings

    For external use only

    Flammable

    • keep away from fire or flame, heat, spark, electrical. Flash point 72°F.

    Ask a doctor before use if you have deep or puncture wounds, animal bites or 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 unless directed by a doctor

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

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

  • Directions

    • clean the affected area
    • apply 1 to 3 times daily
  • Other information

    • 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

  • PRINCIPAL DISPLAY PANEL

    Hydrox

    TRADEMARK
    SINCE 1913

    Warning
    Flammable

    ISOPROPYL ALCOHOL

    91%

    TAMPER EVIDENT CAP FOR YOUR PROTECTION.

    IF RING-BAND IS DETACHED FROM CAP OR MISSING DO NOT USE.

    Principal Display Panel

    Hydrox LABORATORIES

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-071
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Isopropyl Alcohol (UNII: ND2M416302) (Isopropyl Alcohol - UNII:ND2M416302) Isopropyl Alcohol91 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10565-071-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2019
    2NDC:10565-071-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2019
    3NDC:10565-071-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2017
    4NDC:10565-071-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2017
    5NDC:10565-071-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/19/2017
    Labeler - Hydrox Laboratories (025164302)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302MANUFACTURE(10565-071) , label(10565-071) , pack(10565-071)
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