Label: ORAJEL 3X MEDICATED FOR ALL MOUTH SORES- benzocaine, menthol, zinc chloride gel

  • NDC Code(s): 10237-783-12, 10237-783-18, 10237-783-42
  • Packager: Church & Dwight Co., Inc.
  • 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 13, 2022

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  • ACTIVE INGREDIENT

    Benzocaine 20%

    Menthol 0.1%

    Zinc Chloride 0.15%

  • PURPOSE

    Oral pain reliever and Oral astringent

  • Use

    for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums

  • 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 in 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, 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

  • 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 and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • swelling, rash or fever develops
    • irritation, pain or redness persists or worsens
  • KEEP OUT OF REACH OF CHILDREN

    In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 2 years of age and overApply to affected area up to 4 times daily or as directed by a dentist or doctor
    Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
    Children under 2 years of ageDo not use

  • Other information

    do not use if Tamper-Evident Tab is open before first use

  • INACTIVE INGREDIENT

    allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water

  • Questions or comments?

    call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com

  • PRINCIPAL DISPLAY PANEL

    #1 ORAL PAIN

    RELIEF BRAND

    FOR ADULTS

    EXTRA STRENGTH

    Orajel™

    3X MOUTH SORES

    MEDICATED

    IMMEDIATE PAIN RELIEF

    ORAL PAIN

    RELIEVER/

    ASTRINGENT

    Provides

    Long-Lasting

    Pain Relief*

    Helps Protect Sores

    from Irritation

    Delivers Targeted

    Pain Relief

    GEL

    NET WT

    0.18 OZ (5.1 g)

    Orajel 3x Gel - 31840.jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL 3X MEDICATED FOR ALL MOUTH SORES 
    benzocaine, menthol, zinc chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-783
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    POVIDONE (UNII: FZ989GH94E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-783-181 in 1 PACKAGE11/01/2019
    11.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-783-421 in 1 PACKAGE11/01/2019
    24.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:10237-783-121 in 1 PACKAGE11/01/2019
    33.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2019
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-783)
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