Label: MYSIMPLEPETLAB INFECTED SKIN RELIEF- chlorhexidine gluconate, ketoconazole spray

  • NDC Code(s): 86166-103-04, 86166-103-08
  • Packager: Mysimplepetlab Inc
  • 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 March 17, 2023

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

  • Drug Facts

  • Active ingredients

    Chlorhexidine Gluconate 2%
    Ketoconazole 1%

  • Purpose

    Antibacterial
    Antifungal

  • Uses

    • alcohol-free antiseptic (antibacterial and antifungal) formulation designed for dogs with dermatological conditions that are responsive to chlorhexidine and ketoconazole • contains Aloe Leaf Juice and Vitamin E to nourish the skin and further control irritation.

  • Warnings

    For animal use only.
    For topical use only.

    Avoid contact with eyes or mucous membranes. In case of contact, flush eyes with water and seek medical attention if undue irritation persists.
    Consult your veterinarian
    and discontinue use if undue skin irritation develops or increases.
    Keep out of the 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

    Aloe Barbadensis (Aloe) Leaf Juice, Fragrance, Glycerin, Lactic Acid, Methylisothiazolinone, PEG-75 Lanolin, Polysorbate 20, Propylene Glycol, Sodium Lactate, Water.

  • SPL UNCLASSIFIED SECTION

    Vet Approved Pet Care From Home

    Medicated Antiseptic Spray

    Use For Bacterial Or Fungal Skin Conditions

    Formulated For Dogs
    Cucumber Melon Scent

    FORMULATED FOR VETERINARIANS l WITH GLOBALLY SOURCED INGREDIENTS

    MADE IN THE USA

    Distributed by:
    MySimplePetLab Inc.
    Denver, CO 80223

    833-738-8378
    www.MySimplePetLab.com

  • Packaging

    infected skin

  • INGREDIENTS AND APPEARANCE
    MYSIMPLEPETLAB INFECTED SKIN RELIEF 
    chlorhexidine gluconate, ketoconazole spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86166-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 g  in 100 mL
    KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange (Pink) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86166-103-04118 mL in 1 BOTTLE, SPRAY
    2NDC:86166-103-08236 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)