Label: ACETIC ACID solution
Contains inactivated NDC Code(s)
NDC Code(s): 21695-222-15
- Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 50383-889
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 13, 2011
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Acetic Acid Otic Solution, USP is a solution of acetic acid (2%), in a propylene glycol vehicle containing propylene glycol diacetate (3%), benzethonium chloride (0.02%), and sodium acetate (0.015%). The empirical formula for acetic acid is CH3COOH, with a molecular weight of 60.05. The structural formula is:
Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- PEDIATRIC USE
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
Carefully remove all cerumen and debris to allow Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Acetic Acid 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 Acetic Acid 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 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
INGREDIENTS AND APPEARANCE
acetic acid solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-222(NDC:50383-889) 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 20.65 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZETHONIUM CHLORIDE (UNII: PH41D05744) PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O) SODIUM ACETATE (UNII: 4550K0SC9B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-222-15 1 in 1 BOX 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA012179 01/22/2010 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK