Label: CERASOOTHE SA EAR CLEANER- salicylic acid solution
- NDC Code(s): 11695-6989-1, 11695-6989-2
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- 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 June 8, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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DESCRIPTION
CeraSoothe SA
Otic Cleansing Solution
Fragrance: Cucumber melon
Formulated for cats, dogs, and horses
Cleans dries and deodorizes the ear canal. Contains salicylic acid, a beta-hydroxy acid (BHA) to exfoliate and penetrate dead skin cells, wax build-up and dirt. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.
Active ingredients: Salicylic acid 0.15%.
Inactive ingredients: Water, SD alcohol 40-B, propylene glycol, glycerin, benzoic acid, benzyl alcohol, disodium oleamido MIPA sulfosuccinate, nonoxynol-12, diethylhexyl sodium sulfosuccinate, lactic acid, aloe barbadensis (aloe vera) leaf juice, avena sative (oat) kernel oil, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, tetrasodium EDTA.
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INDICATIONS & USAGE
Indications: For use on cats, dogs, and horses to cleanse, deodorize and dry the ear canal.
Directions for use: Ask your veterinarian which of the two following protocols is best for your pet:
1) Moisten a cotton ball with solution and place at the entrance of the ear canal; or
2) Hold ear flap upward and fill with solution.
Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and excess solution with a clean cotton ball. Wask hands after use.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE SA EAR CLEANER
salicylic acid solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6989 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) BENZOIC ACID (UNII: 8SKN0B0MIM) BENZYL ALCOHOL (UNII: LKG8494WBH) DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F) NONOXYNOL-12 (UNII: 6NR43D77O6) DOCUSATE SODIUM (UNII: F05Q2T2JA0) LACTIC ACID (UNII: 33X04XA5AT) ALOE VERA LEAF (UNII: ZY81Z83H0X) AVENANTHRAMIDES (UNII: 5PA41O4AIT) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE EOS (UNII: CR0J8RN66K) CERAMIDE NP (UNII: 4370DF050B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-6989-1 237 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-6989-2 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/30/2021 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
