ORAGESIC ORAL PAIN RELIEVER- benzyl alcohol and menthol, unspecified form solution
Parnell Pharmaceuticals Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ORAGESIC Oral Pain Reliever

Active Ingredient

Benzl Alcohol 1%
Menthol 0.04%

Purpose

Oral Pain Reliever

Uses

temporarily relieves occasional minor irritation, pain, sore mouth and sore throat
temporarily relieves pain associated with canker sores.
temporarily relieves pain due to minor dental procedures.
temporarily relieves pain due to minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

if sore throat is severe, persists for more than 2 days, is accompanied by or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a physician promptly.
if sore throat symptoms do not improve in 7 days, or if irritation, pain or redness persists or worsens see your dentist or physician promptly
do not exceed recommended dosage

Keep out of reach of children

Enter section text here

Directions

use only as directed

adults and children 2 years of age and older (with adult supervision) = apply to the affected area. Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or physician.

children under 2 years of age = ask a doctor or dentist

Other Information

store at room temperature

Inactive Ingredients

ERIODICTYON CALIFORNICUM (YERBA SANTA), FLAVOR, POLYSORBATE 20, SODIUM CHLORIDE, SORBITOL, WATER

Questions or Comments?

1-800-45-PHARM or 1-800-457-4276

www.parnellpharm.com

U.S. Patent Numbers:

4.938.963; 4.983.378

5.015.474

ORAGESIC Oral Pain Reliever 8oz/237ml (50930-099-08)

ORAGESIC

ORAGESIC ORAL PAIN RELIEVER
benzyl alcohol, menthol solution

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:50930-099
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZYL ALCOHOL (BENZYL ALCOHOL)	BENZYL ALCOHOL	10 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM)	MENTHOL, UNSPECIFIED FORM	0.4 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ERIODICTYON CALIFORNICUM LEAF
POLYSORBATE 20
SODIUM CHLORIDE
SORBITOL
WATER

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50930-099-08	237 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	01/02/2013	02/03/2015

Labeler - Parnell Pharmaceuticals Inc (022926067)

Registrant - Parnell Pharmaceuticals Inc (022926067)

Name	Address	ID/FEI	Business Operations
Establishment
Parnell Pharmaceuticals Inc		022926067	manufacture(50930-099)

Revised: 2/2015

Document Id: 4093d883-817d-45c1-b880-8fb5e999bce1

Set id: 3ddbaf9f-a8bb-45ee-867c-85bee80ef744

Version: 2

Effective Time: 20150203

Parnell Pharmaceuticals Inc