ISO-QUIN (ALCOHOL) GEL [PERFORMANCE HEALTH LLC]

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ISO-QUIN (ALCOHOL) GEL [PERFORMANCE HEALTH LLC]
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NDC 59316-994-20, 59316-994-30
Set ID 02933d92-2b12-4b25-866e-0f1d61f6bba5
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 68% 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 not use in or near the eyes.  Discontinue use if irritation or redness develop.  If condition persists for more than 72 hours consult a doctor.  In case of eye contact, flush eyes with water and consult physician.

  • 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.

    Keep out of reach of children.

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

  • Other Information:

    Store in a cool dry place with lid closed tightly

  • Inactive Ingredients:

    Water, PEG-15 Cocamine, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate

  • Questions?

    +1-800 345-2231

  • Package Labeling:

    IsoQuinGel

  • INGREDIENTS AND APPEARANCE
    ISO-QUIN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-994
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL680 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59316-994-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
    2NDC:59316-994-30473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/18/201712/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/18/201712/31/2024
    Labeler - RB Health (US) LLC (081049410)
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