Label: ORAJEL- benzocaine strip

  • 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 January 22, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzocaine 15 mg

    Menthol 2.5 mg

  • PURPOSE

    Benzocaine - Oral Pain Reliever

    Menthol - Oral Pain Reliever

  • INDICATIONS & USAGE

    Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums

  • WARNINGS

    Warnings

    Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried to the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray, or blue colored skin (cyanosis) • headache • rapid heart rate • shortness of breath • dizziness or lightheadedness • fatique or lack of energy

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

  • DO NOT USE

    Do not use • more than directed • for more than 7 days unless directed by a physician or healthcare provider • for teething • in children under 12 years of age

  • STOP USE

    Stop use and ask a phyisican if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • symptoms do not improve in 7 days • allergic reaction occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions • make sure hands are dry and free of moisture as strip may be sticky/tacky • tear open pouch and remove blue strip

    Adults and children 12 years or age and over: Using either side of strip, immediately place directly onto the affected area keeping tongue and lips clear. Gently press for 5-10 seconds until strip adheres to the area. Strip will stay in place and dissolve slowly in mouth for up to 1 hour for duration of treatment. Use up to 4 times daily or as directed by a physician or healthcare provider.

    Children under 12 years of age: Do not use

  • OTHER SAFETY INFORMATION

    Other Information • do not use if pouch is torn or cut prior to opening • do not use continously • for best results, avoid drinking warm beverages or eating for at least one hour after applying the product

  • INACTIVE INGREDIENT

    acid blue 9, glycerin, PEG-8, PEG-90, polycarbophil, potassium sorbate, pullulan, PVP, titanium dioxide, water.

  • QUESTIONS

    Questions • call us at 800 952 5080 Monday through Friday 9am to 5pm or visit our website at www orajel com

  • PRINCIPAL DISPLAY PANEL

    #1 ORAL PAIN

    Reliever Brand

    For Toothache

    NEW!

    SLOW DISSOLVING STRIPS

    For Lasting Relief

    Orajel™

    TOOTHACHE STRIPS

    MEDICATED FOR TOOTHACHE & GUM

    INSTANT & TARGETED PAIN RELIEF

    • Long-Lasting Pain Relief

    •Maximum level of Pain Relief with 15mg Benzocaine*

    •Stays in place for Targeted Relief

    •Soothes gums with Menthol

    Cool Mint Taste

    8 STRIPS

    Individually Wrapped

    Oral Pain Reliever

    OJFC-9986-01.jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL 
    benzocaine strip
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72337-776
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    POLYCARBOPHIL (UNII: W25LM17A4W)  
    ACID BLUE 9 AMMONIUM (UNII: 86R7G3C26F)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72337-776-011 in 1 CARTON01/15/2019
    18 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/05/2018
    Labeler - BioFilm (734555951)
    Registrant - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    BioFilm734555951manufacture(72337-776)