Label: MYSIMPLEPETLAB ITCHY EAR RELIEF- hydrocortisone acetate solution/ drops

  • 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 ingredient

    Hydrocortisone Acetate 0.50%

  • Purpose

    Anti-itch

  • Uses

    soothe: • itching • flea bites • dermatitis • skin irritations • eczema

  • Warnings

    For external use on adult dogs.
    Keep out of reach of children and animals to avoid unintended consumption.

    Do not use • in eyes or nose • where infection (pus) is present, since the drug may allow infection to be spread
    • on pregnant animals
    Not for prolonged use. Do not apply to large areas of the body.
    Stop use and ask veterinarian if redness, irritation, or swelling persists or increases.

  • Directions

    • shake well before use • apply liberally to un-cleaned ear, filling the ear canal • gently massage and work into area • wipe to remove excess. • apply once a day for 7 days • avoid contact with the eyes.

  • Other information

    • store product in a cool, dry place.
    • avoid temperatures above 86° F.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Deionized Water, Dimethyl Sulfoxide, Propylene Glycol.

  • SPL UNCLASSIFIED SECTION

    Vet Approved Pet Care From Home

    Use to Soothe Itching and Ear Irritations

    Formulated for Dogs

    Distributed by:
    MySimplePetLab Inc.
    Denver, CO 80223
    833-738-8378
    www.MySimplePetLab.com

    VETERINARIANS FORMULATED

    WITH GLOBALLY SOURCED INGREDIENTS

    MADE IN THE USA

  • Packaging

    ear drops

  • INGREDIENTS AND APPEARANCE
    MYSIMPLEPETLAB ITCHY EAR RELIEF 
    hydrocortisone acetate solution/ drops
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86166-660
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86166-660-04118 mL in 1 BOTTLE
    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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