Label: STRAWFIELD PETS ANTI-ITCH MEDICATED WITH PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride shampoo

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 20, 2023

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  • ACTIVE INGREDIENTS

    PRAMOXINE HYDROCHLORIDE....1%

  • PRINCIPAL DISPLAY PANEL

    Strawfield Pets Anti Itch (Pramoxine) Shampoo, 16 oz (474 mL) - Amazon

  • INGREDIENTS AND APPEARANCE
    STRAWFIELD PETS ANTI-ITCH MEDICATED  WITH PRAMOXINE HYDROCHLORIDE
    pramoxine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OATMEAL (UNII: 8PI54V663Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86127-102-16474 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
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Safety

Report Adverse Events (Animal Drug), FDA Safety Recalls (Animal Drug)

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Clinical Trials, PubMed, Biochemical Data Summary

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