Label: DOCTOR LEAD M- salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 26, 2018

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  • ACTIVE INGREDIENT

    salicylic acid

  • INACTIVE INGREDIENT

    water, glycerin, dimethicone copolyol, citric acid, etc

  • PURPOSE

    Prevents hair loss, thickens hair root and enables improvement on your scalp.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply the appropriate amount to the scalp, then shampoo and wash away

  • WARNINGS

    Cautions :

    1. When you use this product and find any of following problems, stop using it. if you keep using it despite the problem, the symptom will get worse, so you will have to go see a dermatologist.

    - During use, if you have red spots, swelling, itching, or any other stimuli.

    - if the applied region has any problem above for direct light.

    2. Do not use the product on wound or dermatitis. 3.Attentive points for storage and treatment :

    - Store it in the place where infants or children cannot touch

    - do not store it where it has either high or low temperature or there is direct light.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DOCTOR LEAD M 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71838-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71838-0003-1170 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/26/2018
    Labeler - Kwang Duk Sin Yak Co., Ltd. (688202646)
    Registrant - Kwang Duk Sin Yak Co., Ltd. (688202646)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kwang Duk Sin Yak Co., Ltd.688202646manufacture(71838-0003)
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