Label: SOLV X - salicylic acid shampoo

  • NDC Code(s): 59279-502-06, 59279-502-12, 59279-502-33
  • Packager: Mediceutical Laboratories, LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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

  • Active ingredient

    Salicylic Acid 1.8%

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  • Purpose

    anti-dandruff, anti-seborrheic, dermatitis

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  • Uses

    • Helps control and prevent flaking and itching associated with seborrheic dermatitis
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  • 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.

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  • 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.

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  • 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.
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  • 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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    SOLV X 
    salicylic acid shampoo
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59279-502
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 18 mg  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    ACETIC MONOETHANOLAMIDE  
    AMMONIUM LAURYL SULFATE  
    ASCORBIC ACID  
    BIOTIN  
    FD&C BLUE NO. 1  
    CAMPHOR (SYNTHETIC)  
    COCO DIETHANOLAMIDE  
    COCAMIDOPROPYL BETAINE  
    SARCOSINE  
    HYPROMELLOSES  
    INOSITOL  
    LINOLEIC ACID  
    LINOLENIC ACID  
    MENTHOL  
    PANTHENOL  
    POLYSORBATE 80  
    ALCOHOL  
    JOJOBA OIL  
    SORBITOL  
    .ALPHA.-TOCOPHEROL ACETATE, D-  
    WHEAT GERM OIL  
    WATER  
    ZINC SULFATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59279-502-33 1 L in 1 BOTTLE, PLASTIC
    2 NDC:59279-502-12 0.36 L in 1 BOTTLE, PLASTIC
    3 NDC:59279-502-06 0.18 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/01/1994
    Labeler - Mediceutical Laboratories, LTD (136770067)
    Registrant - Mediceutical Laboratories, LTD (136770067)
    Establishment
    Name Address ID/FEI Business Operations
    United 1 International Laboratories 807878116 manufacture(59279-502)
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