Label: PETE AND PEDRO CONTROL ANTI ITCH DANDRUFF- coal tar shampoo

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 2, 2024

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  • Drug Facts

  • Active Ingredients

    Coal Tar Solution 6.25% (Coal Tar 0.50%)

    Purpose

    Anti-dandruff

  • Uses

    • For relief of the symptoms of dandruff
  • Warnings:

    For external use only.

    Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for upto 24 hours after application.

    Do not use for prolonged periods without consulting doctor.

    Do not use

    • before consulting your doctor, if condition covers a large area of the body.

    When using this product

    • Avoid contact with the eyes.
    • If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    • Apply to affected areas one to four times daily or as directed by a doctor.
  • Other information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    Aqua (Deionized Water), Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Glycerin, SD-Alcohol 408, Menthol, Sodium Chloride, Cocamide MEA, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Caprylyl Glycol, Glycol stearate, Guar Hydroxypropyltrimonium Chloride, Polysorbate 80, Mentha Piperita (Peppermint) Oil, Citrus Aurantium (Bergamot) Oil, FD&C Blue #1.

  • Questions?

    (404) 918-0020

  • Package  Labelling:

    Label.jpg

  • INGREDIENTS AND APPEARANCE
    PETE AND PEDRO CONTROL ANTI ITCH DANDRUFF 
    coal tar shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84503-508
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR62.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: B16G315W7A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84503-508-00236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/25/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/25/2024
    Labeler - PETE AND PEDRO LLC (080927195)
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