Label: SCALP CV68- salicylic acid cream

  • NDC Code(s): 58400-020-01
  • Packager: Pharmco Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 3%

  • Purpose

    For the relief of Seborrheic Dermatitis, Dandruff, and/or Psoriasis.

  • Uses

    For the relief of symptoms associated with seborrheic dermatitis, dandruff, and/or psoriasis, including: itching

    • scaling
    • flaking
    • redness
    • irritation of the skin.

    Helps prevent recurrence.

  • Warnings

    For external use only. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    • If condition worsens or does not improve after regular use of this product as directed, consult a doctor.
    • If condition covers a large area of the body, consult your doctor before using this product. If this product causes increased irritation, discontinue use and seek medical advice.

    Keep out of reach of children. If swallowed get medical help or call a poison control center immediately.

  • Directions

    Use only as directed. Apply to affected areas one to four times daily or as directed by a doctor. Massage well into affected areas. Optimally, this product should be applied to the scalp and left overnight.

  • Other Information

    • Store at room temperature.
  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, C12-15 Alkyl Benzoate, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Prunus Amigdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Hydroxide, Sorbitan Oleate, Triethanolamine, Water.

  • Questions or comments?

    call 1.800.635.0712 Monday through Friday 8:00 AM to 4:30 PM

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Pharmco Laboratories, Inc.
    3520 South St. • Titusville, FL 32780

  • PRINCIPAL DISPLAY PANEL - 96 g Bottle Label

    PHARMCO
    SKINCARE LABS

    Scalp Cream

    Helps Control
    SEBORRHEIC DERMATITIS,
    DANDRUFF & PSORIASIS

    Net wt. 3.4 oz. (96 g)

    PRINCIPAL DISPLAY PANEL - 96 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SCALP   CV68
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58400-020-0196 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03201/01/2018
    Labeler - Pharmco Laboratories, Inc. (096270814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories, Inc.096270814MANUFACTURE(58400-020) , LABEL(58400-020) , PACK(58400-020)