Label: SEREVE PROFESSIONAL SCALP- pyrithione zinc 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 February 25, 2015

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  • ACTIVE INGREDIENT

    Active ingredients: Zinc Pyrithione 2.00%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Polyquaternium-10, Glycerin, Morus Alba Bark Extract, Cocamide DEA, Ammonium Glycyrrhizate, Panthenol, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Rosmarinus officinalis leaf extract, Cnidium officinale root extract, Sophora angustifolia root extract, Panax Ginseng Root Extract, Niacinamide, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Fragrance, Lavender (Lavandula angustifolia) oil, Lawsonia Inermis (Henna) Extract, Acorus Calamus Root Extract, Biotin, EDTA 2Na

  • PURPOSE

    Purpose: Prevent Hair loss

  • WARNINGS

    Warnings: 1. Caution that gets it in your eyes. If get in your eyes, wash your eyes cleanly. The symptoms will get worse and need to consult an ophthalmologist. 2. For external use only. 3. Please do not apply scalp to areas affected by wound or eczema.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indication and usage: 1. Recap the bottle after use. 2. Avoid exposure to a high or low temperature of direct sunlight

  • DOSAGE & ADMINISTRATION

    Dosage and administration: After soak your hair in lukewarm water, make a bubbles with an appropriate amount. Gently massage your scalp and wash hair and scalp with lukewarm water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SEREVE PROFESSIONAL SCALP 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50410-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC5 g  in 250 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50410-080-01250 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/02/2015
    Labeler - Kimjeongmoon Aloe Co., Ltd. (689253722)
    Registrant - Kimjeongmoon Aloe Co., Ltd. (689253722)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kimjeongmoon Aloe Co., Ltd.689253722manufacture(50410-080)
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