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Acetic Acid (Bausch & Lomb Incorporated)

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SOLUTION/ DROPS 1 BOTTLE, PLASTIC in 1 CARTON (24208-615-77) > 60 mL in 1 BOTTLE, PLASTIC Label Information

Complete Acetic Acid Information

  • SPL UNCLASSIFIED SECTION

    Rx only

    FOR USE IN THE EARS ONLY


  • DESCRIPTION

    Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution contains acetic acid 2% as the active ingredient, in a solution containing aluminum acetate (formed from Aluminum Sulfate, Calcium Carbonate, Glacial Acetic Acid), Boric Acid, Purified Water and Sodium Hydroxide. Sodium Hydroxide and/or Glacial Acetic Acid may be added to adjust the pH (3.5-5.0). Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is instilled in the external auditory canal. Acetic acid is an astringent and antimicrobial agent.

    Chemically, acetic acid is C2H4O2 and has the following structural formula:

    Acetic acid (Structural formula)

    Molecular weight: 60.05


  • CLINICAL PHARMACOLOGY

    Acetic acid is antibacterial and antifungal and is effective against microorganisms (bacteria and fungi) that infect the ears of patients with acute diffuse external otitis. In vitro tests, minimum lethal-time was less than 0.25 minutes when bacteria and fungi isolated from patients with otitis externa were exposed to 2% acetic acid. Quantitative absorption of acetic acid 2% from external auditory canal is not known.


  • INDICATIONS AND USAGE

    For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.


  • CONTRAINDICATIONS

    Hypersensitivity to acetic acid or any of the ingredients in this product. Perforated tympanic membranes is considered a contraindication to the use of any external ear canal medication.


  • WARNINGS

    Avoid use or use with caution in patients with perforated tympanic membrane (see CONTRAINDICATIONS).


  • PRECAUTIONS

    General

    Care should be taken to assure that the Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution gets into the ear canal and stays in contact with the affected area long enough for the drug to act.

    Discontinue promptly if sensitization or irritation occurs.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term studies in animals have been performed to evaluate the carcinogenic potential of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.


  • ADVERSE REACTIONS

    Irritation may occur.

    To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


  • OVERDOSAGE

    No toxic effect has been reported with overdosage of Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution.


  • DOSAGE AND ADMINISTRATION

    The patient should lie on the side with the affected ear uppermost. Instill 4 to 6 drops into the external auditory canal and maintain this position for 5 minutes. Repeat the procedure every 2 to 3 hours.


  • HOW SUPPLIED

    Acetic Acid 2% in Aqueous Aluminum Acetate Otic Solution is available in 60 mL plastic squeeze bottle with otic tip.

    NDC 24208-615-77


  • Storage:

    Store between 15Ëš- 25Ëš C (59Ëš-77Ëš F).

    PROTECT FROM FREEZING.

    DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

    KEEP OUT OF REACH OF CHILDREN.

    Revised: May 2016

    Bausch + Lomb, a division of Valeant Pharmaceuticals North America, LLC
    Bridgewater, NJ 08807 USA
    ©Bausch & Lomb Incorporated

    9066904 Folded

    9274304 Flat


  • Principal Display Panel

    Acetic Acid 2% Otic Solution carton

    NDC 24208-615-77

    Acetic Acid 2%
    in Aqueous
    Aluminum
    Acetate Otic
    Solution
    (Sterile)

    FOR USE IN
    EARS ONLY

    Rx only

    60 mL

    BAUSCH + LOMB


  • INGREDIENTS AND APPEARANCE
    ACETIC ACID 
    acetic acid solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-615
    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 2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-615-77 1 in 1 CARTON 02/25/1994
    1 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040063 02/25/1994
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-615)