NOVITA ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [SHIELD LINE LLC]

NOVITA ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [SHIELD LINE LLC]
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NDC 52410-1060-4, 52410-1060-6
Set ID 3ad4e295-2055-0639-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Shield Line LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • DRUG FACTS

    Isopropyl Alcohol 70% (v/v)

  • Purpose

    First Aid Antiseptic

  • Uses

    first aid to prevent the risk of infection in

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    • Flammable, Keep away from fire and flame
    • if taken internally, serious gastric disturbances will result

    Ask a doctor before use if you have

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

    • do not get into eyes
    • do not apply over large areas of body
    • do not use longer than one week unless directed by a doctor
    • do not use otherwise than directed
  • STOP USE

    Stop use and ask a doctor if

    • condition persists or gets worse
  • Keep out of reach of children

    If swallowed, get medical table or contact a Poison Control Center immediately

  • Directions

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

    • store at room temperature
    • does not contain, nor is intended as substitute for grain or ethyl alcohol
  • Inactive Ingredient

    water

  • PRINCIPAL DISPLAY PANEL

    Principal display 12 ozprincipal display 16 oz

  • INGREDIENTS AND APPEARANCE
    NOVITA ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-1060
    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:52410-1060-4355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
    2NDC:52410-1060-6475 mL in 1 BOTTLE; Type 0: Not a Combination Product08/24/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/24/2016
    Labeler - Shield Line LLC (078518916)

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