ORASEP- benzocaine, menthol, cetylpyridinium chloride liquid 
Llorens Pharmaceutical International Division

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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Active Ingredients:

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

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

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

Purpose

Oral anesthetic

Oral antiseptic

Uses for temporary relief of:

 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 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.

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

Directions: 

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

Questions or comments? 1-866-595-5598

OrasepSolLabel

ORASEP 
benzocaine, menthol, cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE2 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 mg  in 100 mL
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-503-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/01/2010
Labeler - Llorens Pharmaceutical International Division (037342305)

Revised: 12/2020
Document Id: e68250f2-c90d-4555-8d98-55b5906df24b
Set id: ed70911b-9da8-4e1d-97fa-66b18d28516a
Version: 4
Effective Time: 20201223
 
Llorens Pharmaceutical International Division