Label: CAREONE MOISTURIZING DANDRUFF WITH ALOE- selenium sulfide 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 March 28, 2018

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  • Active ingredient

    Selenium Sulfide 1%

    Purpose

    Anti-dandruff, anti-seborrheic dermatitis

  • Uses

    for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

  • Warnings

    For external use only.

    Ask a doctor before use if

    you have seborrheic dermatitis in areas other than the scalp.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • for use on color treated or permed hair, rinse thoroughly.

    Stop use and ask a doctor if

    condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • shake well, wet hair, massage onto scalp and rinse.
    • for best results, use at least twice a week or as directed by a doctor.
  • Other information

    store at room temperature.

  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Distearyl Phthalic Acid Amide, Sodium Chloride, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Stearoyl Lactylate, Fragrance (Parfum), Dimethicone, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090).

  • Questions or comments?

    1-877-846-9949

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    CAREONE MOISTURIZING DANDRUFF WITH ALOE 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-623
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-623-11325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/27/2018
    Labeler - American Sales Company (809183973)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(41520-623)
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