Label: CVS PHARMACY DANDRUFF MOISTURIZING 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 October 15, 2010

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-Dandruff

  • Uses

    Controls flaking, scaling and itching associated with dandruff

  • Warnings

    For external use only

    Do Not Use

    • On scalp that is broken or inflamed.
    • If you are allergic to ingredients in this product

    When using this product

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

    Stop using this product and ask doctor if

    • rash appears
    • condition worsens or does not improve in 2-4 weeks

    Keep out of reach of children

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

    If pregnant or breast feeding

    ask a doctor before use

  • Directions

    • Adults and children 12 years and over: wet hair thoroughly, apply shampoo, generously lather, rinse thoroughly. Repeat. Use every 3-4 days for up to 8 weeks or as directed by a doctor. Then use only as needed to control dandruff.
    • Children under 12 years: ask a doctor
  • Other Information

    • store between 35o and 85o F (2o and 30oC)
    • protect from freezing
    • see bottom of bottle for lot number and expiration date
  • 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)

  • Package Front and Back Labels

    ra11.jpg
    11OZ front and back labels
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY DANDRUFF  MOISTURIZING WITH ALOE
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-611
    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:59779-611-11325 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/15/2010
    Labeler - CVS Pharmacy Inc (062312574)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture