Label: ACETIC ACID solution
- NDC Code(s): 64980-424-15
- Packager: Rising Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated May 24, 2021
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Acetic Acid Otic Solution USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP.
The molecular formula for acetic acid is CH 3COOH, with a molecular weight of 60.05. The structural formula is:
Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 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 Acetic Acid 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 of Acetic Acid Otic Solution 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
- PRINCIPAL DISPLAY PANEL - 15 mL bottle
- PRINCIPAL DISPLAY PANEL - 15 mL Carton
INGREDIENTS AND APPEARANCE
acetic acid solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-424 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 20 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O) BENZETHONIUM CHLORIDE (UNII: PH41D05744) SODIUM ACETATE (UNII: 4550K0SC9B) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64980-424-15 1 in 1 CARTON 03/14/2018 1 15 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 ANDA207280 03/14/2018 Labeler - Rising Pharmaceuticals, Inc. (041241766) Registrant - Torrent Pharma inc. (790033935) Establishment Name Address ID/FEI Business Operations Torrent Pharma Inc. 116943196 manufacture(64980-424)