Label: ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID- benzocaine and menthol liquid

  • NDC Code(s): 10237-796-45
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

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 August 7, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Benzocaine 20%

    Menthol 0.1%

  • PURPOSE

    Oral Pain Reliever

  • INDICATIONS & USAGE

    Use for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances

  • WARNINGS

    Methemoglobinemia warning: Use of this product may cuse methemoglobinemia, a serious condition that must be treated promptly becasue it reduces the amount of oxygen carried in 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 or breath • dizziness or lightheadedness • fatigue 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

    Flammable: keep away from fire or flame. Avoid smoking during application.

  • DO NOT USE

    Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor •for teething •in children under 2 years of age

  • STOP USE

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

  • 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 • remove imprinted safety seal from bottle cap

    Adults and children 2 years of age and over

    • Apply product with cotton swab or finger to the affected area. Use up to 4 times daily or as directed by a dentist or doctor

    Children under 12 years of age

    • Ask a doctor before use. Should be supervised in the use of this product

    Children under 2 years of age

    • Do not use

  • OTHER SAFETY INFORMATION

    Other Information • do not use if safety seal on bottle cap is broken or missing prior to opening

  • INACTIVE INGREDIENT

    Inactive Ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5

  • QUESTIONS

    Questions or comment? Call us at 800 952 5080 M-F 9am-5pm or visit our website at www orajel.com

  • PRINCIPAL DISPLAY PANEL

    #1

    ORAL PAIN

    RELIEVER BRAND

    FOR TOOTHACHE

    Fast-Acting Liquid!

    Orajel

    MEDICATED

    FOR TOOTHACHE & GUM

    Instant Pain Relief

    •20% Benzocaine to Relieve Oral Pain

    •Menthol to Soothe Gums

    CANKER SORES • CHEEK BITES • DENTURE PAIN

    IRRITATION FROM BRACES

    ORAL PAIN RELIEVER

    0.45 FL OZ (13.3mL)

    OJFC-32945-07

  • INGREDIENTS AND APPEARANCE
    ORAJEL MEDICATED FOR TOOTHACHE AND GUM, LIQUID 
    benzocaine and menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-796
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 g  in 1 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALCOHOL (UNII: 3K9958V90M)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-796-451 in 1 CARTON08/07/2020
    113.3 mg in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/07/2020
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupac071609663manufacture(10237-796)