Label: ORAJEL INSTANT PAIN RELIEF REGULAR- benzocaine 10% gel

  • NDC Code(s): 10237-745-25
  • 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 20, 2023

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  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Use

    • for the temporary relief of pain due to toothaches
  • Warnings

    Allergy alert: do not use this product if you have a histoy 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
  • ASK DOCTOR

    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 - cut open tip of tube on score mark

    • Adults and children 2 years of age and over - Apply a samll amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
    • Children under 12 years of age - Should be supervised in the use of this product
    • Children under 2 years of age - Ask a physicaian or healthcare provider
  • Other information

    • do not use if tube tip is cut prior to opening
    • this preparation is inteded for use in cases of toothache, only as a temporary expedient until a physician can be consulted
    • do not use continuously
  • Inactive ingredients

    ammonium glycyrrhizate, flavor, polyethylene glycol, sodium saccharin, sorbic acid

  • 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

    Orajel

    MEDICATED

    FOR TOOTHACHE

    INSTANT PAIN RELIEF

    Relieves Oral Pain with 10% Benzocaine

    NET WT

    0.25 oz (7.0 g)

    DA2008700_OJFC-22240-07_72013308

  • INGREDIENTS AND APPEARANCE
    ORAJEL INSTANT PAIN RELIEF  REGULAR
    benzocaine 10% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-745
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-745-251 in 1 PACKAGE12/01/2013
    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 finalpart35612/01/2013
    Labeler - Church Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church Dwight Co., Inc.043690812manufacture(10237-745)
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