Label: ANTI-BACTERIAL LEMON DROP HAND  - triclosan soap 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • ACTIVE INGREDIENT

    Active ingredient:
    Triclosan 0.3%
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  • PURPOSE

    Purpose
    Antimicrobial
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  • INDICATIONS & USAGE

    KILLS MORE THAN 99.99% OF COMMON GERMS
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  • WARNINGS

    FOR EXTERNAL USE ONLY. DO NOT USE IN THE EYES. Close
  • STOP USE

    DISCONTINUE USE IF IRRITATION AND REDNESS DEVELOP. IF CONDITION PERSISTS FOR MORE THAN 72 HOURS, CONSULT A DOCTOR.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. CHILDREN CAN ONLY USE THIS PRODUCT WITH ADULT SUPERVISION.
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  • DOSAGE & ADMINISTRATION

    DIRECTIONS:
    WET HANDS.APPLY PALMFUL TO HANDS. SCRUB THOROUGHLY. RINISE. RECOMMENDED FOR REPEATED USE.
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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:Water, Sodium Alkyl Ether Sulphate, Ammonium Lauryl Sulphate, Cocamidopropyl Betaine, Cocamide DEA, Disodium Laureth Sulfosuccinate, Sodium Chloride, Glycol Distearate, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Disodium EDTA, FD&C Yellow NO. 5

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  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL LEMON DROP HAND  
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53603-2013
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM C12-15 PARETH-3 SULFATE  
    AMMONIUM LAURYL SULFATE  
    COCAMIDOPROPYL BETAINE  
    COCO DIETHANOLAMIDE  
    DISODIUM LAURETH SULFOSUCCINATE  
    SODIUM CHLORIDE  
    GLYCOL DISTEARATE  
    METHYLCHLOROISOTHIAZOLINONE  
    METHYLISOTHIAZOLINONE  
    CITRIC ACID MONOHYDRATE  
    EDETATE DISODIUM  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53603-2013-8 236.6 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/06/2012
    Labeler - BB17, LLC (828378294)
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