Label: ORASEP- benzocaine, menthol, cetylpyridinium chloride liquid

  • NDC Code(s): 54859-504-01
  • Packager: Llorens Pharmaceutical International Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 23, 2020

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  • 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

    OrasepSpray

  • INGREDIENTS AND APPEARANCE
    ORASEP 
    benzocaine, menthol, cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-504
    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:54859-504-0130 mL in 1 BOTTLE, SPRAY; 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)
    Registrant - Llorens Pharmaceutical International Division (037342305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lex Inc.046172888manufacture(54859-504)
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