Label: BENZOYL PEROXIDE 3%- benzoyl peroxide shampoo

  • NDC Code(s): 86069-123-12
  • Packager: Stratford Care Usa, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 23, 2022

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Benzoyl Peroxide 3%

  • PURPOSE

    ANTISEBORRHEIC & ANTISEPTIC

  • INDICATIONS & USAGE

    Benzoyl Peroxide Shampoo is a powerful cleansing formula for the relief of scaling and itching associated with skin infection, seborrheic disorders and follicular plugging on dogs, cats and horses. Formulated with a soap-free, lathering shampoo base with skin moisturizers for gentle cleaning and deodorizing, Benzoyl Peroxide Shampoo has antiseptic properties and effectively removes scales and oils from the coat.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Propylene Glycol, Acrylates Copolymer, Sulfur, Tocopheryl Acetate (Vitamin E), Diethylhexyl Sodium Sulfosuccinate, Fragrance, Sodium Hydroxide.

  • DOSAGE & ADMINISTRATION

    Directions for use: Shake well before use. Wet the hair coat with warm water. Apply and lather first on the affected area then apply and lather on the entire hair coat. Allow to remain on hair for 5 to 10 minutes then rinse thoroughly with clean water. Repeat if necessary. May be used 2 to 3 times per week or as directed by your veterinarian.

  • PRECAUTIONS

    Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.

  • STORAGE AND HANDLING

    Storage: Store at controlled room temperature.

  • SPL UNCLASSIFIED SECTION

    FOR DOGS, CATS & HORSES

    ANTIMICROBIAL

    PASSION FRUIT SCENT

    Stratford Animal Care
    A MEMBER OF THE SWEDENCARE FAMILY

    Distributed by:
    StratfordCare USA
    Odessa, FL 33556
    877-498-2002
    www.stratfordrx.com

  • Packaging

    SHAMPOO-123

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 3% 
    benzoyl peroxide shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    SULFUR (UNII: 70FD1KFU70)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86069-123-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2022
    Labeler - Stratford Care Usa, Inc. (036650469)