Label: ISO-QUIN- alcohol liquid

  • NDC Code(s): 59316-997-20, 59316-997-30, 59316-997-50
  • Packager: Performance Health, LLC
  • 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 August 7, 2022

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  • Drug Facts

  • Active Ingredients

    Alcohol Denat 65% v/v

    Purpose

    Antiseptic

  • Uses:

    Helps decrease bacteria on the skin. Recommended for repeated use.

  • Warnings

    For external use only.

    Flammable-keep away from fire or flame.

    When using this product 

    Use in a well-ventilated area. Do use in or near the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. In case of eye contact, flush eyes with water and consult a physician.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Apply a small amount onto hands and rub briskly until dry. Do not rinse. Children under 6 years of age should be supervised when using this product.

  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Inactive Ingredients:

    Water, Isopropyl Alcohol, Fragrance, Yellow #11

  • Questions?

    +1800 345-2231

  • 59316-997-20

    Bottle14

  • 59316-997-30

    Bottle15

  • 59316-997-50

    Bottle16

  • INGREDIENTS AND APPEARANCE
    ISO-QUIN 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-997
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-997-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/201712/31/2024
    2NDC:59316-997-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/201712/31/2024
    3NDC:59316-997-503785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/19/201712/31/2024
    Labeler - Performance Health, LLC (794324061)
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