Label: ISO-QUIN- alcohol gel

  • NDC Code(s): 59316-994-20, 59316-994-30
  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • 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 - Performance Health, LLC (794324061)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!