Label: MEDICEUTICALS X-DERMA DRY SCALP AND HAIR TREATMENT- 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 December 28, 2015

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

  • Active Ingredient

    Salicylic Acid 1.8%

  • Purpose

    Anti-dandruff, anti-seborrheic dermatitis

  • Uses

    Helps prevent recurrence of flaking and itching
    associated with dandruff and seborrheic dermatitis.

  • Warnings

    For external use only. If condition worsens or does not improve after regular use of this product as directed, discontinue and consult a physician. If condition covers a large area of the body, consult your physician before using this product.

  • Keep this and all drugs out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with cool water.

  • Directions

    1. Wet hair with warm water. Distribute shampoo evenly onto scalp
    and hair creating a rich lather. Rinse.
    2. Reapply for maximum results. Rinse. Apply Therapeutic™ Scalp and
    Hair Treatment Rinse working onto scalp and through the hair.
    3. Thoroughly rinse.
    Consult your Salon professional for additional Mediceuticals® scalp
    and hair treatments specifically tailored for your condition.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Apigenin, Biotin, Biotynoyl Tripeptide-1, Butylene
    Glycol, Butylphenyl Methyl Propional, Chamomilla Recutita (Matricaria) Flower
    Extract, Citric Acid, Citronellol, Cocamide DEA, Cocamidopropyl Betaine, Cucumis
    Sativus (Cucumber) Extract, Dimethicone, Fragrance (Parfum), Glycerin, Glycol
    Stearate, Helianthus Annuus (Sunflower) Seed Extract, Linalool, Methylchloroisothiazolinone,
    Methylisothiazolinone, Oleanic Acid, Panthenol, PEG-40 Hydrogenated
    Castor Oil, PEG-150 Distearate, PPG-26-Buteth-26, Simmondsia Chinensis
    (Jojoba) Seed Oil, Sodium C14-16 Olefin Sulfonate, Water (Aqua)

  • Image of Label

    MediceuticalXDermaLabel180mL.jpg Label

  • INGREDIENTS AND APPEARANCE
    MEDICEUTICALS X-DERMA  DRY SCALP AND HAIR TREATMENT
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-507
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    APIGENIN (UNII: 7V515PI7F6)  
    BIOTIN (UNII: 6SO6U10H04)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    1-BUTENE (UNII: LY001N554L)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CUCUMBER SEED (UNII: BT3S9L53JK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59279-507-06180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:59279-507-12360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:59279-507-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/27/2012
    Labeler - Mediceutical Laboratories, Ltd. (136770067)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dhaliwal Laboratories, LLC016754201manufacture(59279-507)