Label: BENZOYL PEROXIDE 3%- benzoyl peroxide shampoo

  • NDC Code(s): 68898-121-12
  • Packager: Animal Pharmaceuticals
  • 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 21, 2022

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

  • Drug Facts

  • Active Ingredients

    Benzoyl Peroxide , USP 3%

  • Purpose

    Antiseborrheic

  • Inactive Ingredients

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

  • Uses:

    a medicated shampoo with antiseborrheic and antiseptic activity for dogs, cats and horses.

  • 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

    For topical use in dogs, cats, and horses. Avoid contact with the eyes or mucous membranes. If contact occurs, rinse thoroughly with water and consult a veterinarian. MAY BLEACH COLORED FABRICS.

  • Cautions

    If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

    Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

  • SPL UNCLASSIFIED SECTION

    Antiseborrheic and Antiseptic Shampoo

    Passionfruit

    Formulated for Dogs, Cats & Horses

    At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond....and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

    OUR ASSURANCE
    Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

    Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

    ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% QUALITY GUARANTEED.

    To learn more about our products, visit:

    www.anmpharm.com

    SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

    MANUFACTURED FOR
    Animal Pharmaceuticals

    MADE IN THE USA

  • Packaging

    anmpharm-121

  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE 3% 
    benzoyl peroxide shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:68898-121
    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:68898-121-12355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/15/2021
    Labeler - Animal Pharmaceuticals (166472444)
    Registrant - Stratford Care Usa, Inc. (036650469)