ORTIZOL OTIC SOLUTION- antipyrine, benzocaine, phenylephrine hydrochloride liquid

Ortizol by

Drug Labeling and Warnings

Ortizol by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC, Consumer Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Each ml contains:

Antipyrine USP 50 mg

Benzocaine USP 50 mg

Phenylephrine HCL USP 1.25 mg

PURPOSE

The analgetic action of antipyrine and

benzocaine to relief pressure. reduce

inflammation and congestion. and allevate

pain and discomfort in acute otitis media.

INDICATIONS & USAGE

For the relief of pain and the reduction of

inflammation in acute otitis media. It is also

useful in the removal of excessive or

impacted cerumen.

WARNINGS

Hipersensitivity to any of the components or

substances related to them. In the presence

of spontaneous perforation or discharge.

DO NOT USE

ASK DOCTOR/PHARMACIST

WHEN USING

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Warm to body temperature and fill the ear

canal with 2 to 4 drops. Moisten cotton

pledget with the solution and gently insert

into the ear canal.

Repeat 3 or 4 times daily.

OTHER SAFETY INFORMATION

Store at controlled

room temperature 25 °C

(77 ºF).

Protect from freezing.

Keep tightly closed.

Keep this and all

medications out of reach

of children.

INACTIVE INGREDIENT

Sodium

Metabisulfite NF 1 mg.

Propylene Glycol USP

897.75 mg.

QUESTIONS

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORTIZOL  OTIC SOLUTION
antipyrine, benzocaine, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61841-180
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANTIPYRINE (UNII: T3CHA1B51H) (ANTIPYRINE - UNII:T3CHA1B51H)	ANTIPYRINE	50 mg  in 1 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	1.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61841-180-05	1 in 1 CARTON	12/19/2014
1		15 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
Export only		12/19/2014

Labeler - Bayer HealthCare LLC, Consumer Care (785159372)