Label: ORAJEL DENTURE PAIN RELIEF- benzocaine, benzalkonium chloride, menthol gel

  • 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 October 18, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

    Benzocaine 20%

    Menthol 0.7%

  • PURPOSE

    Benzalkonium Chloride - Oral antiseptic

    Benzocaine - Oral pain reliever

    Menthol - Oral pain reliever

  • INDICATIONS & USAGE

    Use for the temporary relief of • pain due to minor irritation of the mouth and gums caused by dentures • occasional minor irritation, pain, sore mouth.

  • WARNINGS

    Warnings

    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 physician or healthcare provider

  • STOP USE

    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 • allergic reaction occurs

  • 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

    cut open tube on score mark

    Adults and children 2 years of age and over:

    Apply a thin layer to the affected area. Do not reinsert dental work until irritation/pain is relieved. Rinse out well before reinserting. 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 physician or healthcare provider

    Other Information • do not sue if tube tip is cut prior to opening • this preparation is intended for use in cases of denture pain, only as a temporary expedent until a physician can be consulted • do not use continuously • Orajel Denture Pain Gel will stay in place for extended duration of relief

  • INACTIVE INGREDIENT

    Inactive Ingredients blue 1, cellulose gum, flavor, gelatin, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin, water

  • QUESTIONS

    Questions or comments call us at 800 952 5080 Monday through Friday 9-5 or visit our website www orajel com

  • PRINCIPAL DISPLAY PANEL

    #1

    Oral Pain

    Reliever Brand

    For Adults

    New Formula!

    3x More

    Active Ingredients*

    Orajel

    Instant Pain Relief

    For Denture Pain

    Soothes Gum Pain & Irritation

    Triple Medicated

    10% Benzocaine to Relieve Pain from Dentures

    Astringent to Relieve Gum Irriation NEW

    Menthol to Soothe Gums Irritated by Dentures

    Refreshing Mint

    Long-Lasting Gel

    Oral Pain Reliever/Astringent NET WT 0.25 OZ (7.0g)

    OJFC-38405-03

  • INGREDIENTS AND APPEARANCE
    ORAJEL DENTURE PAIN RELIEF 
    benzocaine, benzalkonium chloride, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-765
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL26 mg  in 1 g
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    PECTIN (UNII: 89NA02M4RX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GELATIN (UNII: 2G86QN327L)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-765-251 in 1 CARTON07/01/201610/18/2019
    11 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 finalpart35607/01/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.253933600manufacture(10237-765)