Label: MYSIMPLEPETLAB ITCHY SKIN RELIEF- hydrocortisone, pramoxine hydrochloride spray

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

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Drug Label Information

Updated March 16, 2023

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  • Drug Facts

  • Active ingredients

    Hydrocortisone 1%

    Pramoxine Hydrochloride 0.5%

  • Purpose

    Anti-itch

  • Uses

    helps relieve symptoms of:

    • hot spots • bites • skin conditions

  • Warnings

    For animal use only.
    For topical use only.
    Avoid contact with eyes or mucous membranes.
    Consult your veterinarian if eye contact occurs and rinse thoroughly with water.
    Consult your veterinarian and discontinue use if undue skin irritation develops or increases.
    Keep out of reach of children.

  • Directions

    • spray directly onto the affected area(s) up to 3 times daily, or as directed by veterinarian
    • do not allow animal to lick the treated areas until dry to prevent ingestion.
  • Other information

    Store at controlled room temperature.

  • Inactive ingredients

    Benzyl Alcohol, Glycerin, Hydrolyzed Oats, PEG-75 Lanolin, Propylene Glycol, SD Alcohol 40B, Water.

  • SPL UNCLASSIFIED SECTION

    Vet Approved Pet Care From Home

    Formulated for Dogs

    FORMULATED FOR VETERINARIANS

    WITH GLOBALLY SOURCED INGREDIENTS

    MADE IN THE USA

    Distributed by:
    MySimplePetLab Inc.
    Denver, CO 80223

    833-738-8378
    www.MySimplePetLab.com

  • Packaging

    itchyskinrelief

  • INGREDIENTS AND APPEARANCE
    MYSIMPLEPETLAB ITCHY SKIN RELIEF 
    hydrocortisone, pramoxine hydrochloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86166-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OAT (UNII: Z6J799EAJK)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86166-120-04118 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2023
    Labeler - Mysimplepetlab Inc (118813078)
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Safety

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Clinical Trials, PubMed, Biochemical Data Summary

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