Label: SOLV X- 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 October 1, 2012

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 control and prevent flaking and itching associated with 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

    For best results use daily or until condition is under control or as directed by a physician.

    For maximum control use every time you shampoo.

    1. Wet hair, massage liberal amount of Solv-XTM onto the scalp and through the hair
    2. Thoroughly rinse and repeat if desired
    3. Apply TherapeuticTM Scalp and Hair Treatment Rinse for 1-2 minutes, thoroughly rinse.
    Consult your Salon professional for additional Mediceuticals® scalp and hair treatments specifically tailored for your condition.
  • Inactive ingredients

    Acetamide MEA, Ammonium Lauryl Sulfate, Ascorbic Acid (Vitamin C), Biotin, Blue 1 (Cl 42090), Camphor, Cocamide DEA, Cocamidopropyl Betaine, Cocoyl Sarcosine, Fragrance (Parfum), Hydrolyzed Glycosaminoglycans, Hydrolyzed Hair Keratin, Hydroxypropyl Methylcellulose, Inositol, Linoleic Acid,  Linolenic Acid, Menthol, Panthenol, Polysorbate 80, SD Alcohol 40-B, Simmondsia Chinesis (Jojoba) Seed Oil, Sorbitol, Sodium Cocoyl Collagen Amino Acid, Tocopheryl Acetate, Triticum Vulgare (Wheat) Germ Oil, Water (Aqua), Wheat Germ Acid, Zinc Sulfate

  • Package Label-Principal Display Panel

    SOLV-XTM

    OILY SCALP AND HAIR TREATMENT SHAMPOO

    MEDICEUTICALS®

    Cruelty Free. Not tested on Animals.

    Sold exclusively through fine Salons, Spas and Hair Restoration Clinics

    Manufactured in the USA for:

    Mediceutical Laboratories, LTD Fort Worth, Texas 76118

    Customer Service: 1-800-433-2903

    Mediceutical Europe B.V.

    Kelvinstraat 61,2723 RJ Zoetermeer The Netherlands EU

    Telephone: +31 79 3314029

    NDC 5927950233 SOLV-X 33.8 fl oz

    NDC 5927950206 SOLV-X 6 fl oz

    NDC 5927950212 SOLV-X 12 fl oz

    Front

    SolvXFront

    Back

    SolvXBack

  • INGREDIENTS AND APPEARANCE
    SOLV X 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59279-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID18 mg  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC MONOETHANOLAMIDE (UNII: A9O0818TWD)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BIOTIN (UNII: 6SO6U10H04)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SARCOSINE (UNII: Z711V88R5F)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    INOSITOL (UNII: 4L6452S749)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    MENTHOL (UNII: L7T10EIP3A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALCOHOL (UNII: 3K9958V90M)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBITOL (UNII: 506T60A25R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    WATER (UNII: 059QF0KO0R)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59279-502-331 L in 1 BOTTLE, PLASTIC
    2NDC:59279-502-120.36 L in 1 BOTTLE, PLASTIC
    3NDC:59279-502-060.18 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/01/1994
    Labeler - Mediceutical Laboratories, LTD (136770067)
    Registrant - Mediceutical Laboratories, LTD (136770067)
    Establishment
    NameAddressID/FEIBusiness Operations
    United 1 International Laboratories807878116manufacture(59279-502)