Label: MYSIMPLEPETLAB INFECTED EAR RELIEF- ketoconazole solution
- NDC Code(s): 86166-111-04, 86166-111-12
- 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 December 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
-
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
• shake well before use • apply liberally to the affected area(s) • apply twice daily or as directed by veterinarian • use cotton or absorbent material to clean excess solution and wipe away debris • do not allow the animal to lick the treated area until dry to prevent ingestion • wash hands after use.
- Other information
- Inactive ingredients
-
SPL UNCLASSIFIED SECTION
Vet Approved Pet Care From Home
Medicated Tris Flush
Topical Antiseptic Solution For Cleansing & Flushing Of Ears
Formulated For Dogs
Cucumber Melon Scent
MADE IN THE USA
FORMULATED FOR VETERINARIANS | WITH GLOBALLY SOURCED INGREDIENTS
Distributed by:
MySimplePetLab Inc.
Denver, CO 80223
833-738-8378
www.MySimplePetLab.com - Packaging
-
INGREDIENTS AND APPEARANCE
MYSIMPLEPETLAB INFECTED EAR RELIEF
ketoconazole solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86166-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 0.1 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) NONOXYNOL-9 (UNII: 48Q180SH9T) ALCOHOL (UNII: 3K9958V90M) TROMETHAMINE (UNII: 023C2WHX2V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86166-111-04 118 mL in 1 BOTTLE 2 NDC:86166-111-12 355 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/01/2023 Labeler - Mysimplepetlab Inc (118813078)
