HYDROCORTISONE AND ACETIC ACID- hydrocortisone and acetic acid otic solution

hydrocortisone and acetic acid by

Drug Labeling and Warnings

hydrocortisone and acetic acid by is a Prescription medication manufactured, distributed, or labeled by Saptalis Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

DESCRIPTION: Hydrocortisone and Acetic Acid Otic Solution, USP is a solution containing hydrocortisone (1%) and acetic acid (2%), in a propylene glycol vehicle containing benzethonium chloride (0.02%), citric acid (0.05%), propylene glycol diacetate (3%) and sodium acetate (0.015%). The empirical formulas for acetic acid and hydrocortisone are CH3COOH, and C21H30O5, with a molecular weight of 60.05 and 362.46, respectively. The structural formulas are:

Hydrocortisone and Acetic Acid is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY: Acetic acid is antibacterial and antifungal; hydrocortisone is antiinflammatory, antiallergic and antipruritic; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

INDICATIONS & USAGE

INDICATIONS AND USAGE: For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by inflammation.

CONTRAINDICATIONS

CONTRAINDICATIONS: Hypersensitivity to Hydrocortisone and Acetic Acid or any of the ingredients; herpes simplex, vaccinia and varicella. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

WARNINGS: Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

PRECAUTIONS: Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

PEDIATRIC USE: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS: Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC at 1-833-727-8254 or FDA at 1-­800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Carefully remove all cerumen and debris to allow Hydrocortisone and Acetic Acid to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with Hydrocortisone and 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 Hydrocortisone and 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 Hydrocortisone and 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

HOW SUPPLIED: Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), is available in 10 mL, measured-drop, safety-tip plastic bottles (NDC: 71656-064-10).

SPL UNCLASSIFIED SECTION

STORAGE: Store at room temperature, 20° to 25°C (68° to 77°F). Keep container tightly closed.

Rx only

Distributed by:
Saptalis Pharmaceuticals, LLC
Hauppauge, NY 11788

MADE IN USA

January 2024-R2
PPM-0082

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 71656-064-10

Hydrocortisone and Acetic Acid Otic Solution, USP

1% / 2%

For Otic Use Only

Rx only

10 mL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC: 71656-064-10

Hydrocortisone and Acetic Acid Otic Solution, USP

1% / 2%

For Otic Use Only.

Rx only

10 mL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE AND ACETIC ACID 
hydrocortisone and acetic acid otic solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71656-064
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	20.75 mg  in 1 mL
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10.375 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)
SODIUM ACETATE (UNII: 4550K0SC9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71656-064-10	1 in 1 CARTON	01/16/2024
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA012770	01/16/2024

Labeler - Saptalis Pharmaceuticals, LLC (080145868)

Registrant - Saptalis Pharmaceuticals, LLC (080145868)

Establishment
Name	Address	ID/FEI	Business Operations
Saptalis Pharmaceuticals, LLC		081154447	manufacture(71656-064)