Label: PETE AND PEDRO- coal tar solution and menthol shampoo lotion/shampoo

  • NDC Code(s): 52261-0900-1
  • Packager: Cosco International, Inc.
  • 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 January 24, 2019

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  • DRUG FACTS

    Active Ingredients:

    Coal Tar Solution 1.8%..................Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

    Menthol 1.5%..............................Contols scalp itch

  • PURPOSE

    Uses:  Product relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis.  Provide relief of itching due to dandruff.

  • WARNINGS

    Warnings:  For external use only.

  • DO NOT USE

    Do not use for prolonged periods without consulting a doctor or with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a physician.

  • ASK DOCTOR

    Ask a doctor before use if you have a conditiion that covers a large area of the body.

  • INDICATIONS & USAGE

    When using this product avoid contact with the eyes.  If contact occurs, rinse thoroughly with water.  Use caution in exposing skin to sunlight after applying.  It may increase you tendency to sunburn for up to 24 hours after application.

  • STOP USE

    Stop use and ask doctor if condition worsens or does not improve after regular use of the product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Shake well and apply shampoo to wet hair.  Gently massage it into hair and scalp to work up a lather.  Rinse hair thoroughly and repeat for best results.  Use at least twice a week or as directed by a doctor.

  • STORAGE AND HANDLING

    Other Information:  Store at room temperature between 68-78

  • INACTIVE INGREDIENT

    Inactive Ingredients:  Caprylyl Glycol, Citric Acid, Cocamide MEA, Cocamidopropyl Betaine, Ethanol, FD&C Blue #1, Glycerin, Guar Gum, Hydroxypropyl Methylcellulose, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Sodium Laureth Sulfate, Water, Zinc Stearate

  • QUESTIONS

    Questions:  1 (404) 918-0020 or www.peteandpedro.com

  • WARNINGS

    WARNING:  This product contains a chemical known to the State of California to cause cancer.

  • PRINCIPAL DISPLAY PANEL

    8oz Label8oz Label8oz Label8oz Label

  • INGREDIENTS AND APPEARANCE
    PETE AND PEDRO 
    coal tar solution and menthol shampoo lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-0900
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR0.001836 kg  in 1 kg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.00153 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GUAR GUM (UNII: E89I1637KE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-0900-10.260 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/24/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/24/2019
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-0900) , label(52261-0900) , pack(52261-0900)
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