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Name:Otic Care Antipyrine And Benzocaine
Manufacturer:Puretek Corporation
Category:Prescription Marketed Drugs


Otic Care Otic Solution Antipyrine, Benzocaine Rx Only

OTIC CARE ANTIPYRINE AND BENZOCAINE  - antipyrine and benzocaine solution 
PureTek Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Otic Care Otic Solution Antipyrine, Benzocaine Rx Only

DESCRIPTION:

Each mL contains:
Antipyrine...........................................5.4%
Benzocaine........................................1.4%


TOPICAL ANESTHETIC AND ANALGESIC:

Otic Care Otic Solution
contains antipyrine, benzocaine, acetic acid, aluminum acetate, aluminum oxide, glycerin and policosanol. The solution congeals at 0°C (32°F) but returns to normal consistency, unchanged at room temperature.

The structures of the components are:
molecular structures

INACTIVE INGREDIENTS:

Acetic Acid, Aluminum Acetate, Aluminum Oxide, Glycerin, Policosanol.

CLINICAL PHARMACOLOGY:

Otic Care Otic Solution combines the properties of acetic acid, policosanol and aluminum acetate with the analgesic action of antipyrine and the local anesthetic action of benzocaine to relieve pressure, reduce inflammation and congestion, and alleviate pain and discomfort in acute otitis media. Does not blanch the tympanic membrane or mask the landmarks and therefore, does not distort the otoscopic picture.

INDICATIONS AND USAGE:

Acute otitis media of various etiologies:

  • Rapid pain relief and reduction of inflammation in the congestive and serous stages of otitis media.
  • Adjuvant therapy during systemic antibiotic administration.
Removal of earwax:
  • Facilitates the removal of excessive or impacted earwax.

CONTRAINDICATIONS:

  • Hypersensitivity to any of the components or substances related to Otic Care Otic Solution.
  • In case of tympanic membrane perforation or discharge.

PRECAUTIONS:


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. Consult your physician.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Consult your physician.

ADVERSE REACTIONS:

Call your doctor for medical advice about side effects. You may report suspected side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

Warm to body temperature (37°C or 98°F) by holding the bottle in the hand for a few minutes. To apply eardrops, wash your hands first. To avoid contamination do not touch the dropper or let it touch your ear or any surface. Instill Otic Care Otic Solution by tilting the affected ear upward, holding the dropper directly over the ear, and placing the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted about two minutes. Moisten a cotton pledget with Otic Care Otic Solution and insert into the opening of the ear canal. Repeat every one to two hours until pain and congestion is relieved.


REMOVAL OF EARWAX:

Instill Otic Care Otic Solution three times daily for two or three days to help detach cerumen from wall of canal and facilitate removal.

Otic Care Otic Solution is useful for drying out the canal or relieving discomfort.


Before and after removal of cerumen, insert a cotton pledget saturated with Otic Care Otic Solution into the meatus.

If swallowed or overdose is suspected, contact your local Poison Control Center or emergency room immediately. You may call US National Poison Hotline at 1-800-222-1222.

Note: Do not rinse dropper after use.

Replace dropper in bottle after each use. Hold dropper assembly by screw cap and, without compressing the rubber bulb, insert into drug container and screw down tightly.

Protect the solution from light and heat, and do not use if it is brown or contains a precipitate.

DISCARD THIS PRODUCT SIX MONTHS AFTER DROPPER IS FIRST PLACED IN THE DRUG SOLUTION.

HOW SUPPLIED:

14 mL of Otic Care Otic Solution ear drops are supplied in a white plastic bottle with separate dropper with screw cap attachment and package insert, NDC 59088-864-02.

WARNING:

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

STORAGE:

Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Protect from freezing. Keep container tightly closed.

Image Label

image of label


OTIC CARE ANTIPYRINE AND BENZOCAINE 
antipyrine, benzocaine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-864
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANTIPYRINE (ANTIPYRINE) ANTIPYRINE 54 uL  in 1 mL
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 uL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM ACETATE  
ALUMINUM OXIDE  
GLYCERIN  
ERICERUS PELA POLYCOSANOL  
ACETIC ACID  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59088-864-02 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 14 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (59088-864-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/10/2011

Labeler - PureTek Corporation (785961046)
Establishment
Name Address ID/FEI Operations
PureTek Corporation 785961046 manufacture, label, pack, outsourcing human drug compounding, relabel, repack

Revised: 06/2011 PureTek Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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