ORASEP- benzocaine, menthol, cetylpyridinium chloride liquid

Orasep by

Drug Labeling and Warnings

Orasep by is a Otc medication manufactured, distributed, or labeled by Llorens Pharmaceutical International Division, Lex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Benzocaine...................... 2%      Anesthetic

Cetylpyridinium Chloride..........0.1% Antiseptic

Menthol.................................0.5% Anesthetic

PURPOSE

Purpose

Oral anesthetic

Oral antiseptic

INDICATIONS & USAGE

Uses for temporary relief of:

• Occasional minor sore throat pain and dry scratch throat.
• Pain due to canker sores. Pain due to minor irritation or injury of the mouth and gums. Pain due to minor dental procedures, minor irritations cause by dentures or orthodontic appliances.

WARNINGS

 Warnings:

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or any other 'caine' anesthetics.

Sore throat warning: If sore throat is sever, persists for more than2 days, is accompanied or followed by fever, headache, rash, nausea, or vomitings, consult a doctor promptly. 

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, or if irritation, pain or redness persist or worsens.

Do not exceed recommended dosage.

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep this and all drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

PREGNANCY OR BREAST FEEDING

If pregnant or breast feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION

Directions: 

• Adults and children 6 years of age or older: spray into throat or onto affected area with one spray per use. Use up to 4 times daily or as directed by a doctor or dentist
• Children under 6 years of age: ask a doctor or dentist.

INACTIVE INGREDIENT

Inactive Ingredients: Artificial and natural flavors, methylparaben, polyoxyl hydrogenated castor oil, propylene glycol, propylparaben, purified water, and sucralose.

QUESTIONS

Questions or comments? 1-866-595-5598

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORASEP 
benzocaine, menthol, cetylpyridinium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54859-504
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	2 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 mg  in 100 mL
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54859-504-01	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/01/2010

Labeler - Llorens Pharmaceutical International Division (037342305)