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Orajel Instant Relief for Teething Pain (Church & Dwight Co., Inc.)

Available Formats

Dosage Form Package Information Links
GEL 1 TUBE in 1 CARTON (10237-714-33) > 9.4 g in 1 TUBE Label Information

Complete Orajel Instant Relief for Teething Pain Information

  • ACTIVE INGREDIENT


    Active Ingredients
    Benzocaine 7.5%

  • PURPOSE

    Purpose
    Oral pain reliever


  • INDICATIONS & USAGE


    Use    for the temporary relief of sore gums due to teething in children 2 years of age and older.  For use in children under the age of 2, consult a physician or healthcare provider.
  • WARNINGS

    Allergy Alert
    do not use this product if our child has 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 physician or healthcare provider

    When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection.  If these symptoms persist, consult your physician.

    Stop use and ask a dentist of doctor if sore mouth symptoms do not improve in 7 days, irritation, pain or redness does not go away, swelling, rash or fever develops
  • 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

    wash hands,
    cut open tip of tube on score mark,
    use your fingertip or cotton applicator to apply a small pea-size amount of ORAJEL and spread over the gums
    apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider,
    for children under 2 years of age, consult a physician or healthcare provider


    Other information
    Do not use if tube tip is cut prior to opening.



  • INACTIVE INGREDIENT

    Inactive ingredients  ammonium glycyrrhizate, cucumis sativus (cucumber) fruit extract, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, sodium saccharin, sorbic acid, sorbitol, sucralose


    Questions or comments?  call us at 1-800-952-5080 Mon-Fri 9am-5pm ET or visit our website at www.orajel.com



  • Principal Display Carton

    NO 1 TEETHING BRAND
    recommended by Pediatricians

    Orajel
    Instant Relief
    for Teething Pain            dye free      melon flavored gel

    CONTAINS CUCUMBER EXTRACT   KEEP IN REFRIGERATOR FOR EXTRA COOLING

    COOLING CUCUMBER
    COOLS AND SOOTHES TENDER GUMS


    NET WT 0.33 OZ (9.4G) GEL            ORAL PAIN RELIEVER FOR TEETHING    BENZOCAINE 7.5%


    carton image
    carton image

  • INGREDIENTS AND APPEARANCE
    ORAJEL INSTANT RELIEF FOR TEETHING PAIN  COOLING CUCUMBER
    benzocaine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-714
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 75 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCYRRHIZIN, AMMONIATED (UNII: 3VRD35U26C)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBIC ACID (UNII: X045WJ989B)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10237-714-33 1 in 1 CARTON
    1 9.4 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 06/15/2010
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    Name Address ID/FEI Business Operations
    Church & Dwight Co., Inc. 043690812 manufacture