Home > Drugs A-Z > Orajel for Toothache

Orajel for Toothache (Church & Dwight Co., Inc.)

Available Formats

Dosage Form Package Information Links
SWAB 12 APPLICATOR in 1 CARTON (10237-705-12) > 1.8 mL in 1 APPLICATOR Label Information

Complete Orajel for Toothache Information

  • ACTIVE INGREDIENT

    Active ingredient                    Purpose
    Benzocaine 20%                   Oral Pain Reliever

    Uses for the temporary relief of pain due to toothaches

    Warnings
    Allergy Alert

    do not use this product if your 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 told to do so by a dentist or doctor

    Stop use and ask a dentist of doctor if symptoms do not get better 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 awayEnter section text here

    Directions

    Adults and Children                     Hold swab with solid white tip down
    2 years of age and older              Bend and snap open swab tip with the colored rings
                                                     Apply product to the cavity and around gum surrounding the                                                     teeth
                                                     Use up to 4 times daily or as directed by a dentist or doctor
                                                     Discard swab after application

    Children under 12 years of age   Should be supervised in the use of this product

    Children under 2 years of age      Ask a dentist or doctor

    Other information do not use if label seal is broken prior to purchase, or if colored rings on tip are not blue, this preparation is intended for use in cases of toothache, only as temporary expedient until a dentist can be consulted, do not use continuously

    Inactive ingredients flavor, polyethylene glycol, purified water, red 40, sodium saccharin, yellow 5

    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

    Carton image

    Carton image


  • INGREDIENTS AND APPEARANCE
    ORAJEL FOR TOOTHACHE  MAXIMUM STRENGTH
    benzocaine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-705
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 0.2 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-705-12 12 in 1 CARTON
    1 1.8 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 08/11/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    SwabPlus, Inc. 876441549 manufacture