Label: OTOZIN- antipyrine, benzocaine and zinc acetate solution
- NDC Code(s): 28595-420-20
- Packager: Allegis Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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- SPL UNCLASSIFIED SECTION
Each 1 mL for otic administration contains:
Antipyrine 54 mg Benzocaine 10 mg Zinc Acetate Dihydrate 10 mg
Also contains acetic acid, propylene glycol, glycerin, purified water, and vitamin E polyethylene glycol 1000 succinate.
Antipyrine is an antipyretic and analgesic. Antipyrine occurs as a colorless, almost odorless, crystalline powder or tabular crystals having a slightly bitter taste. It is very soluble in water and freely soluble in alcohol. Chemically its structure is C11H12N20.
Benzocaine is a short-acting local anesthetic. Benzocaine occurs as a white, crystalline powder. Chemically its structure is C9H11NO2.
Zinc acetate in the dihydrate form is a salt of zinc and a topical skin protectant generally recognized as safe and effective. Zinc acetate dihydrate occurs as white crystals or granules, is freely soluble in water and in boiling alcohol and is slightly soluble in alcohol. Chemically its structural formula is C4H6O4Zn•2H2O.
TOPICAL DECONGESTANT, ANALGESIC, & SKIN PROTECTANT
An otic solution containing antipyrine, benzocaine and zinc acetate dihydrate.
- CLINICAL PHARMACOLOGY
Combines the analgesic action of antipyrine and benzocaine with the skin protectant zinc acetate to relieve pressure, reduce inflammation and congestion, protect the skin, and alleviate pain and discomfort in acute otitis media.
- INDICATIONS AND USAGE
Acute otitis media of various etiologies
- Prompt relief of pain and reduction of inflammation in the congestive and serous stages.
- Adjuvant therapy during systemic antibiotic administration for resolution of the infection.
Because of the close anatomical relationship of the Eustachian tube to the nasal cavity, otitis media is a frequent problem especially in children in whom the tube is shorter, wider and more horizontal than in adults.
This product is contraindicated in any person with hypersensitivity to any of the components or substances related to them. This product is contraindicated in the presence of spontaneous perforation of the tympanic membrane or discharge.Close
Information for Patients
Avoid contaminating the dropper with material from the ear, fingers or other source.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term studies in animals or humans have been conducted.
Pregnancy Category C
Animal reproduction studies have not been conducted with this preparation. It is also not known whether this product can cause fetal harm when administered to a pregnant woman, or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.
- DOSAGE AND ADMINISTRATION
Acute otitis media
Warm to body temperature. Using a single bottle dropper, instill the product permitting the solution to run along the wall of the canal until it is filled. Avoid touching the ear with the dropper. Repeat every one to two hours until pain and congestion are relieved.
Removal of cerumen
Instill three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.
- HOW SUPPLIED
OTOZIN is supplied as a clear liquid delivered in 2 white dropper bottles containing 10 mL each as a single prescription package (NDC 28595-420-20).Close
- SPL UNCLASSIFIED SECTION
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.
U.S. Patent # 6,093,417
Canton, MS 39046
- PRINCIPAL DISPLAY PANEL - Two 10 mL Bottle Carton
Zinc Acetate Dihydrate 1.0%
Canton, MS 39046
Two 10 mL
- INGREDIENTS AND APPEARANCE
antipyrine, benzocaine, and zinc acetate solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:28595-420 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Antipyrine (UNII: T3CHA1B51H) (Antipyrine - UNII:T3CHA1B51H) Antipyrine 54 mg in 1 mL Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine 10 mg in 1 mL Zinc Acetate (UNII: FM5526K07A) (Zinc - UNII:J41CSQ7QDS) Zinc Acetate 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Glycerin (UNII: PDC6A3C0OX) Acetic Acid (UNII: Q40Q9N063P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:28595-420-20 2 in 1 BOX 1 10 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/06/2011 Labeler - Allegis Pharmaceuticals, LLC (792272861)