Label: PHYLLIS GOLDEN HAIR- oatmeal 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 21, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient: OATMEAL

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    WATER, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, PEG-7 GLYCERYL COCOATE, GLYCINE, SOJA (SOYBEAN) SEED EXTRACT, DECYL SODIUM CHLORIDE,
    POLYQUATERNIUM-10, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, BAMBUSA ARUNDINACEA STEM EXTRACT,
    PHASEOLUS RADIATUS SEED EXTRACT, LAMINARIA DIGITATA EXTRACT, GOLD, CITRIC ACID, BENZOPHENONE-5, DISODIUM EDTA, METHYLISOTHIAZOLINONE,
    METHYLCHLOROISOTHIAZOLINONE, FRAGRANCE

  • PURPOSE

    Purpose:

    It appears to protect from harmful ultraviolet rays as well as preventing oxidation.
    Alleviates skin trouble from sensitive scalp while making glossy healthy hair.

  • WARNINGS

    WARNINGS:

    Use of the products should be discontinued if the following adverse reactions occur. As continued use may make symptoms worse, it is advisable to consult a dermatologist, Redness, swelling, itching, and sensitivity.
        Redness, swelling, itching, and sensitivity caused by direct sunlight.
    Do not use the products on sun burnt areas, wounded, eczema or dermatitis-affected regions.
    If the product gets into your eyes, rinse your eyes with clean water.
    Caution rinse thoroughly. If not, may cause loss of hair or discoloration

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    Replace the caps after use.

    Keep away from babies and children.

  • INDICATIONS & USAGE

    How to Use:

    Apply to wet or damp hair with soft massage and rinse thoroughly.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:

    Apply to wet or damp hair with soft massage and rinse thoroughly.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PHYLLIS GOLDEN  HAIR
    oatmeal shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52841-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.004 mL  in 400 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCINE (UNII: TE7660XO1C)  
    GOLD (UNII: 79Y1949PYO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52841-010-01400 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2010
    Labeler - UNOCOS CO., LTD. (557799050)
    Registrant - UNOCOS CO., LTD. (557799050)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNOCOS CO., LTD.557799050manufacture
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