FOUR SEASON (PYRITHIONE ZINC) SHAMPOO [ONELINESUN CO., LTD.]

FOUR SEASON (PYRITHIONE ZINC) SHAMPOO [ONELINESUN CO., LTD.]
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NDC 61616-010-01
Set ID 4b6c29bc-c0ad-4598-b08d-6363c9bcfdf8
Category HUMAN OTC DRUG LABEL
Packager OneLineSun Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART358H
  • ACTIVE INGREDIENT

    Active Ingredient: Zinc Pyrithione 0.60%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Water, Cocamidopropyl Betaine, Sodium Cocoyl Alaninate, Sodium Lauroyl Methylaminopropionate, Panax Ginseng Root Extract, Thuja Occidentalis Leaf Extract, Morus Alba Bark Extract, Chrysanthemum Zawadskii Extract, Lycium Chinense Fruit Extract, Acorus Gramineus Root/Steam Extract, Xanthium Strumarium Fruit Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Menthea Arvensis Extract, Propylene Glycol, Cocamide Menthyl MEA, PEG-7 Glyceryl Cocoate, PEG-150 Distearate, Polyquaternium-10, Disodium EDTA, PPG-3 Myristyl Ether, Menthol, Parfum, Salicilic Acid, Panthenol, PCA, Betaine, sodium Lactate, Sodium Chloride, Arginine, Magnesium nitrate, Menthylchlorosothiazolinone, Methylisothiazolinone, Magnesium Chloride, Acorus Calamus Root Extract, Camellia Sinensis Leaf Extract

  • PURPOSE

    Purpose: Antidandruff

  • WARNINGS

    Warnings:
    1. It is not used in the following cases.
    Skin and scalp there is a skin wound or mucous membrane, such as eczema, damaged
    2. People such as the following, consult your doctor and pharmacist before using this medicine
    People who have (such as dermatitis rash, redness, itching, with lacquer, etc.) allergy symptoms caused by cosmetics and medicine came out
    3. Be discontinued immediately the use of this drug in the following cases, consult your doctor or pharmacist, at the time of consultation, as far as possible, be in possession of this package insert
    1) If rash, erythema, itching, swelling, and the like are displayed
    2) If severe pain and itching as displayed
    4. Notes when using this drug other
    1) To be used only for the outside. The (non-oral)
    2) Be careful so that it does not get in your eyes, flush with clean water when it gets if, it is recommended that you consult with an ophthalmologist if symptoms are severe.
    3) Be careful when you are repeating the same site, because it may scalp becomes rough degreasing etc. (degreasing).

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN: Keep out of reach of babies and children.

  • INDICATIONS AND USAGE

    INDICATIONS AND USAGE:
    Is taken up in the original container, and to store in a separate container that it may cause quality degradation or accident caused by any misuse, be in original container and store in tightly closed.

  • DOSAGE AND ADMINISTRATION

    DOSAGE AND ADMINISTRATION:
    After wetting the hair with lukewarm water, to soften the scalp 3-5mL, and evenly paint the hair, massage the scalp.
    Wait three minutes or more in the state that issued the foam and put to wash clean.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    FOUR SEASON 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61616-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1.8 mg  in 300 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61616-010-01300 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/01/2013
    Labeler - OneLineSun Co., Ltd. (689003976)
    Registrant - OneLineSun Co., Ltd. (689003976)
    Establishment
    NameAddressID/FEIBusiness Operations
    OneLineSun Co., Ltd.689003976manufacture(61616-010)

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