Label: STRAWFIELD PETS BENZOYL PEROXIDE MEDICATED WITH PRECIPITATED SULFUR- benzoyl peroxide shampoo

  • 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 June 20, 2023

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  • ACTIVE INGREDIENTS

    BENZOYL PEROXIDE GEL, USP....2.5%

    PRECIPITATED SULFUR, USP....2.0%

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Benzoyl Peroxide Medicated Shampoo (AMZ)_474mL

    01b LBL_Benzoyl Peroxide Medicated Shampoo (Reg)_474mL

  • INGREDIENTS AND APPEARANCE
    STRAWFIELD PETS BENZOYL PEROXIDE MEDICATED  WITH PRECIPITATED SULFUR
    benzoyl peroxide shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-104-16474 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2023
    Labeler - NEXTMUNE AB (352950223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Veterinary Services LLC619511483manufacture, api manufacture