Label: ORAJEL GUM PAIN 3X MEDICATED- benzocaine, menthol, zinc chloride gel

  • NDC Code(s): 10237-792-12
  • 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 20, 2023

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  • Active ingredients

    Benzocaine 20%

    Menthol 0.26%

    Zinc chloride 0.15%

  • Purpose

    Oral pain reliever and Oral astringent

  • Use

    for the temporary relief of pain due to 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

  • 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

    • 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 older

    • Apply to affected area up to 4 times daily or as directed by a dentist or doctor

    Children between 2 and 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 information

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

  • Inactive ingredients

    ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, 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

    RELIEVER BRAND

    FOR ADULTS

    Open Tube Tip

    Orajel

    GUM PAIN

    3X MEDICATED GEL

    INSTANT PAIN RELIEF

    20% Benzocaine to Relieve Gum Pain

    Cooling Relief to Soothe Gums

    Relieves Gum Irritation

    ORAL PAIN RELIEVER/ASTRINGENT

    NET WT

    0.125oz (3.5g)

    CR2_DA2044058_OJFC-00500-01_72016656

  • INGREDIENTS AND APPEARANCE
    ORAJEL GUM PAIN 3X MEDICATED 
    benzocaine, menthol, zinc chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-792
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM2.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-792-121 in 1 PACKAGE12/17/2019
    13.5 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 finalpart34812/17/2019
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-792)
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