Label: O SHA MPOO PREMIUM- glycerin shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 28, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Disodium Laureth Sulfosuccinate 30.0%, Cocamidopropyl Betaine 8.0%, Glycerin 2.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Polyquaternium-10, Dimethicone, Panthenol, Menthol, Malt Extract, Sodium Hyaluronate, Sodium Benzoate, Rosmarinus Officinalis (Rosemary) Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Symphytum Officinale Leaf Extract, Urtica Dioica (Nettle) Extract, Tocopheryl Acetate, Sorbic Acid, Sophora Angustifolia Root Extract, Eclipta Prostrata Extract, Panax Ginseng Root Extract, Lycium Chinense Fruit Extract, Polygonum Multiflorum Root Extract, Disodium EDTA, Paeonia Albiflora Root Extract, Acorus Gramineus Root/Stem Extract, Thuja Orientalis Extract, Scutellaria Baicalensis Root Extract, Cnidium Officinale Root Extract, Citrus Unshiu Peel Extract, Chaenomeles Sinensis Fruit Extract, Methylisothiazolinone, Laminaria Japonica Extract, Rehmannia Chinensis Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Zingiber Officinale (Ginger) Root Extract, Perilla Frutescens Leaf Extract, Pinus Palustris Leaf Extract, Methylchloroisothiazolinone.

  • PURPOSE

    Purpose : Shampoo (cleaning hair and scalp)

  • WARNINGS

    Warnings: 1. Discontinue to use this production if the below symptoms occure in use : Damage on the skin or scalp such as mucosa, scar or eczema. 2. In case of having following symptoms, consult the medical specialist before use. In case of having allergy(like red rash, swollenness, itching, dermatitis) caused by drug or cosmetics. 3. Immediately stop using and consult the medical specialist for below cases. (Consult with this affixation, if possible.) (a)In case of having problems such as red rash, swollenness, itching stimulation during usage (b) In case of having pruritis or pain. 4. Others caution in usage. (a)External use only.(Internal use forbidden.) (b)Be careful not to get it into your eyes and in case you have to wash it immediately and consult the medical specialist if the symptom gets worse. (c)Be careful of overuse so that the scalp could not lose its oil and it gets roughen. 5. Caution in storage (a)Protect from light and heat. Store in the shade. (b)Keep out of reach of children. (c)Causing accident or degradation from keeping in the different containers from the oriinal container, keep in the designated container with airtight lid.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications and usage: 1. Better to wash in the evening to get rid of foreign substances on the scalp accumulated during the day. 2. A through wash is required. 3. Dry in a mild-warm air 4. Wash face and/or shave with bubbles left on hair for 1 to 2 minutes before washing out. 5. Do not use rinse products while using O shampoo 6. Taking half-bath with bubbles on the hair makes you feel fresh.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: Use an adequate amount of this product Suggested use is once a day.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    O SHA MPOO PREMIUM 
    glycerin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71043-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7.5 g  in 300 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71043-010-01300 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/01/2016
    Labeler - Herbearth (689059857)
    Registrant - Herbearth (689059857)
    Establishment
    NameAddressID/FEIBusiness Operations
    Herbearth689059857manufacture(71043-010)