ISO-QUIN (ALCOHOL) LIQUID [PERFORMANCE HEALTH, LLC]

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ISO-QUIN (ALCOHOL) LIQUID [PERFORMANCE HEALTH, LLC]
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NDC 59316-997-20, 59316-997-30, 59316-997-50
Set ID 21149553-77fc-43a1-af89-823115cb5759
Category HUMAN OTC DRUG LABEL
Packager RB Health (US) LLC
Generic Name
Product Class
Product Number
Application Number PART333E
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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 - RB Health (US) LLC (081049410)
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