Label: 70% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

  • NDC Code(s): 72976-001-01, 72976-001-02, 72976-001-03, 72976-001-04, view more
    72976-001-05, 72976-001-06, 72976-001-07
  • Packager: SZY Holdings, LLC dba EverReady First Aid
  • 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 15, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient (by volume)

    Isopropyl Alcohol (70%)

  • PURPOSE

    Purpose

    First Aid Antiseptic

  • INDICATIONS & USAGE

    Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • WARNINGS

    Warnings

    For external use only

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

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns
  • WHEN USING

    When using this product

    • do not get into eyes
    • do not apply over large areas of the 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

    Keep out of reach of children

    In case of ingestion, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • clean effected 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
  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    70% ISOPROPYL RUBBING ALCOHOL
    FIRST AID ANTISEPTIC
    16 FL.OZ (473 mL)

    label

  • INGREDIENTS AND APPEARANCE
    70% ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72976-001
    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:72976-001-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    2NDC:72976-001-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    3NDC:72976-001-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    4NDC:72976-001-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    5NDC:72976-001-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    6NDC:72976-001-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    7NDC:72976-001-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - SZY Holdings, LLC dba EverReady First Aid (147372960)
    Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jell Pharmaceuticals Pvt. Ltd.726025211manufacture(72976-001)
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