Label: OBEO HAIR- 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 May 15, 2017

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  • ACTIVE INGREDIENT

    Salicylic Acid 1.8%

  • PURPOSE

    Seborrheic Dermatitis Treatment

  • INDICATIONS & USAGE

    For the relief of symptoms associated with Seborrheic Dermatitis including itching, scaling, flaking, redness and
    irritation of the scalp. Helps prevent recurrence

  • DOSAGE & ADMINISTRATION

    Apply a suitable amount to hair. After massaging gently, leave on scalp for two minutes and rinse with water

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    Stop using and ask a doctor if rash occurs

    When using this product, keep out of eyes. Rinse with water to remove

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium chloride, Methylparaben, Piroctone Olamine, Disodium Laureth Sulfosuccinate, Disodium EDTA, Salicylic Acid, PEG-120 Methyl Glucose Dioleate, Steartrimonium Chloride, Propylene Glycol, Propylene Glycol, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Cocamide MIPA, Laureth-4, Laureth-23, Sodium Benzoate, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Polyquaternium-68, Laureth-2, Laureth-3, Hydrolyzed Collagen, Propylene Glycol, Glycine, Serine, Alanine, Butylene Glycol, Silk Amino Acids, Bis(C13-15 Alkoxy) PG-Amodimethicone, Polygonum Multiflorum Root Extract, Butylene Glycol, Silt, Pearl Extract, Caramel, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    OBEO HAIR 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69871-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID9 mg  in 500 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-23 (UNII: N72LMW566G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYQUATERNIUM-68 (UNII: R76MNN6P72)  
    LAURETH-2 (UNII: D4D38LT1L5)  
    LAURETH-3 (UNII: F32E4CB0UJ)  
    GLYCINE (UNII: TE7660XO1C)  
    SERINE (UNII: 452VLY9402)  
    ALANINE (UNII: OF5P57N2ZX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AMINO ACIDS, SILK (UNII: V0L00EX1IA)  
    FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69871-007-021 in 1 CARTON05/15/2017
    1NDC:69871-007-01500 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/15/2017
    Labeler - CPbio Co., Ltd (689514410)
    Registrant - CPbio Co., Ltd (689514410)
    Establishment
    NameAddressID/FEIBusiness Operations
    CPbio Co., Ltd689514410manufacture(69871-007)