Label: HYDROCORTISONE AND ACETIC ACID solution
- NDC Code(s): 51672-3007-1
- Packager: Taro Pharmaceuticals U.S.A., Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 2, 2019
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- SPL UNCLASSIFIED SECTION
Hydrocortisone and Acetic Acid Otic Solution, USP contains Hydrocortisone (1%) and acetic acid, glacial (2%) in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.2%), propylene glycol diacetate (3%) and sodium acetate (0.015%).
Acetic acid has a molecular formula of CH3COOH with molecular weight of 60.05. The structural formula is:
Hydrocortisone is a Synthetic Steroid used as an anti-inflammatory and antipruritic agent. Its chemical name is Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11β)-. Hydrocortisone has a molecular formula of C21H30O5 with molecular weight 362.46. The structural formula is:
Hydrocortisone and acetic acid is available as a non-aqueous otic solution buffered at pH (2.0 to 4.0) for use in the external ear canal.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Carefully remove all cerumen and debris to allow hydrocortisone 1% and acetic acid 2% otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton
INGREDIENTS AND APPEARANCE
HYDROCORTISONE AND ACETIC ACID
hydrocortisone and acetic acid solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-3007 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 10.4 mg in 1 mL Acetic Acid (UNII: Q40Q9N063P) (Acetic Acid - UNII:Q40Q9N063P) Acetic Acid 20.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength propylene glycol (UNII: 6DC9Q167V3) propylene glycol diacetate (UNII: 5Z492UNF9O) benzethonium chloride (UNII: PH41D05744) sodium acetate (UNII: 4550K0SC9B) anhydrous citric acid (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-3007-1 1 in 1 CARTON 04/28/2005 1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088759 04/28/2005 Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-3007)