Label: ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM- benzalkonium chloride, benzocaine, menthol, zinc chloride gel

  • NDC Code(s): 10237-787-25
  • 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 January 10, 2023

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  • Active Ingredients

    Belzalkonium chloride 0.13%

    Benzocaine 20%

    Menthol 0.5%

    Zinc chloride 0.15%

  • Purpose

    Oral antiseptic, Oral pain reliever, Oral astringent

  • Use

    • for the temporary relief of pain due to minor irritation or injury of the mouth and gums
    • first aid to help prevent infection in minor oral irritation
  • 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 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, 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

    • 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 over

    • 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
    • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • Inactive Ingredients

    ammonium glycyrrhizate, blue 1, 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 TOOTHACHE

    Ready-Open Tube Tip

    Orajel

    4X MEDICATED FOR TOOTHACHE AND GUM GEL

    INSTANT PAIN RELIEF

    Clinical Strength for Pain Relief

    Proven to Kill Harmful Bacteria

    Helps Prevent Infection

    Cooling Relief for Gum Irritation

    ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT

    NET WT

    0.25 oz (7.0 g)

    OJFC-32503-08.jpg

  • INGREDIENTS AND APPEARANCE
    ORAJEL 4X MEDICATED FOR TOOTHACHE AND GUM 
    benzalkonium chloride, benzocaine, menthol, zinc chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-787
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg  in 1 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBIC ACID (UNII: X045WJ989B)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-787-251 in 1 PACKAGE11/01/2019
    12.5 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 FINALpart333A11/01/2019
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812MANUFACTURE(10237-787)
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