Label: SKIN AND SCALP- coal tar 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 September 1, 2016

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

  • DRUG FACTS

    Active ingredients Purpose
    Coal tar solution 8.5% v/v .......................................................................Psoriasis, Atopic & Seborrheic
    (Equivalent to 1.7% Coal tar)............................................................................. Dermatitis & Dandruff

  • USES

    Controls symptoms of Psoriasis, Atopic & Seborrheic Dermatitis & Dandruff. • Relieves itching, flaking, scaling, & scalp irritation.

  • WARNINGS


    For external use only: Ask a doctor before use if your body has a condition that which covers a large part of the body. Keep out of reach of children. When using this product: Do not use for a prolonged period of time without consulting a doctor. Do not use with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Shake well, for best results use at least twice a week or directed by a doctor. For shampooing, wet hair thoroughly, massage shampoo into the scalp. Lather, leave on scalp for several minutes. Rinse and repeat. For body wash, add a small amount to damp wash cloth and wash the affected areas. Rinse and repeat

  • PURPOSE

    Controls symptoms of: • Seborrheic Dermatitis, • Psoriasis, • Minor & Severe Dandruff, • Relief of scalp & skin itching, irritation & flaking associated with Atopic Dermatitis

  • OTHER INFORMATION

    In rare instances, discoloration of gray, blonde, bleached or tinted hair may occur.

  • INactive

    Inactive ingredients Water, alcohol (5%), sodium lauryl sulfate, sodium laureth sulfate, cocamidopropyl betaine, eucalyptus oil,
    cocamide DEA methylparaben, benzoic acid, propylparaben, PEG 150 Distearate, camphor, vitamin E acetate (DL-alpha-tocopheryl acetate),
    vitamin A palmitate (Retinyl Palmitate), jojoba oil, menthol, vitamin H (biotin), polysorbate 80, fragrance, citric acid.

  • questions or comments

    Questions or comments Toll free number: 1-855-458-2400, Fax: 1-972-228-2400 or info@albradewynllc.com

  • KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Uses • Controls symptoms of Psoriasis, Atopic & Seborrheic Dermatitis & Dandruff. • Relieves itching, flaking, scaling, & scalp irritation.

  • PRINCIPAL DISPLAY PANEL

    4 oz

  • INGREDIENTS AND APPEARANCE
    SKIN AND SCALP 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59151-645
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR17 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    COCAMIDOPROPYL DIMETHYLAMINE PROPIONATE (UNII: 83750MLC4A)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BIOTIN (UNII: 6SO6U10H04)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MENTHOL (UNII: L7T10EIP3A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59151-645-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2016
    Labeler - Albra Dewyn LLC (069451336)
    Establishment
    NameAddressID/FEIBusiness Operations
    Albra Dewyn LLC069451336manufacture(59151-645)