Label: ISO-QUIN- alcohol gel

  • 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 July 30, 2014

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  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients                                                 Purpose

    Alcohol (SDA 40-2) 68% by volume.......................Antiseptic

  • Uses

    Use whenever soap and water handwashing is not possible and to supplement handwashing. Recommended for repeated use.  Use for cleaning hands between treatments.

  • Warnings


    Flammable - keep away from fire or flame. For external use only. Do not use in the eyes.  Keep away from eyes.  In case of eye contact, flush eyes with water and consult a physician.  In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.  Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a small amount onto hands and rub briskly until dry.  Do not rinse. Wash with soap after 10 - 15 applications or if hands are visibly soiled.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Ethomeen, Carbomer, Fragrance, Aloe Vera Gel, Vitamin E Acetate

  • QUESTIONS

    Stock No. 093042   Mfd. by Cramer Products, Inc. Gardner, Kansas 66030 USA

    QUESTIONS? (800) 345-2231 (M-F 8:00AM-5:00PM CST)

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children.

  • PURPOSE

    Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    image descriptionISO-QUIN GEL 4 oz


    Hand Disinfectant

    World Leader in Sports Medicine Since 1918

    Minimizes Spread of Germs, Infection

    For Cleaning Hands Between Treatments

    NET 4 Fl Oz (118 mL)

  • INGREDIENTS AND APPEARANCE
    ISO-QUIN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11960-0550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11960-0550-7118 mL in 1 BOTTLE06/14/2000
    2NDC:11960-0550-9473 mL in 1 BOTTLE06/14/2000
    3NDC:11960-0550-8473 mL in 1 BOTTLE, PUMP07/31/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/14/2000
    Labeler - Cramer Products, Inc (007138183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cramer Products, Inc007138183manufacture(11960-0550) , pack(11960-0550) , label(11960-0550)
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