ORTIZOL OTIC SOLUTION- antipyrine, benzocaine, phenylephrine hydrochloride liquid 
Bayer HealthCare LLC, Consumer Care

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Ortizol-Otic Solution

Each ml contains:

Antipyrine USP 50 mg

Benzocaine USP 50 mg

Phenylephrine HCL USP 1.25 mg

The analgetic action of antipyrine and

benzocaine to relief pressure. reduce

inflammation and congestion. and allevate

pain and discomfort in acute otitis media.

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.

Hipersensitivity to any of the components or

substances related to them. In the presence

of spontaneous perforation or discharge.

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.

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.

Sodium

Metabisulfite NF 1 mg.

Propylene Glycol USP

897.75 mg.

ortizol

ORTIZOL  OTIC SOLUTION
antipyrine, benzocaine, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61841-180
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANTIPYRINE (UNII: T3CHA1B51H) (ANTIPYRINE - UNII:T3CHA1B51H) ANTIPYRINE50 mg  in 1 mL
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE1.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61841-180-051 in 1 CARTON12/19/2014
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only12/19/2014
Labeler - Bayer HealthCare LLC, Consumer Care (785159372)

Revised: 2/2015
Document Id: 0e57dc35-674d-5880-e054-00144ff88e88
Set id: 0e57dc35-674c-5880-e054-00144ff88e88
Version: 1
Effective Time: 20150205
 
Bayer HealthCare LLC, Consumer Care