Label: FIRST AID ANTISEPTIC- 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 February 2, 2021

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  • SPL UNCLASSIFIED SECTION

    This is a first aid antiseptic manufactured according to FDA Guidance.

  • Active Ingredient(s)

    Isopropyl Alcohol 91% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Antiseptic to decrease germs in minor cuts and scrapes abd for preparation of skin prior to an injection; Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Clean the affected area; apply small amount of product on the area 1 to 3 times daily.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    purified water USP

  • Package Label - Principal Display Panel

    473 ml NDC: 79363-910-16

    91% IPA ProtectRxx 16 oz

    91% IPA Eclipse 16 oz91% IPA Lifesguard 16 oz

    946 ml NDC: 79363-910-32

    91% IPA Lifesguard 32 oz

    91% IPA ProtectRxx 32 oz

    91% IPA Eclipse 32 oz

    237ml NDC:79363-910-08

    91% IPA ProtectRxx 8 oz

    3785ml NDC:79363-910-28

    91% IPA ProtectRxx 1 Gallon

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79363-910
    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:79363-910-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    2NDC:79363-910-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    3NDC:79363-910-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    4NDC:79363-910-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product08/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2020
    Labeler - REALCHEM MANUFACTURING (120491681)
    Establishment
    NameAddressID/FEIBusiness Operations
    REALCHEM MANUFACTURING117584702manufacture(79363-910) , pack(79363-910) , repack(79363-910)
    Establishment
    NameAddressID/FEIBusiness Operations
    REALCHEM MANUFACTURING117742005manufacture(79363-910) , pack(79363-910) , repack(79363-910)
    Establishment
    NameAddressID/FEIBusiness Operations
    REALCHEM MANUFACTURING117828480manufacture(79363-910) , pack(79363-910) , repack(79363-910)
    Establishment
    NameAddressID/FEIBusiness Operations
    REALCHEM MANUFACTURING120491681manufacture(79363-910) , pack(79363-910) , repack(79363-910)
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