Label: RITE AID MOISTURIZING DANDRUFF MEDICATED FORMULA- 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 22, 2012

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  • Active Ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-Dandruff

  • Uses

    For relief of flaking and itching due to dandruff, for seborrheic dermatitis, and to help prevent their recurrence.

  • Warnings

    For external use only

    Ask a doctor before using if you have

    seborrheic dermatitis in areas other than the scalp.

    When using this product

    avoid contact with the eyes. If contact occurs, rinse eyes 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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Shake well. Shampoo, then rinse thoroughly.
    • For best results, use at least twice a week or as directed by a doctor.
  • Questions/Comments?

    1 - 866 - 695 - 3030

  • Inactive Ingredients:

    Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic Acid Amide, Cocamide DEA, Fragrance (Parfum), Titanium Dioxide, Dimethicone, Hydroxypropyl Methylcellulose, Citric Acid, Sodium Isostearoyl Lactylate, DMDM Hydantoin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Sodium Chloride, Blue 1 (CI 42090)

  • Label copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    RITE AID MOISTURIZING DANDRUFF  MEDICATED FORMULA
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6111-1325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/20/2012
    Labeler - Rite Aid Corporation (014578892)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture
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