Label: BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel severe pm toothache and gum relief cream

  • NDC Code(s): 10237-771-25
  • Packager: Church & Dwight Co., Inc.
  • 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 December 17, 2019

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

  • ACTIVE INGREDIENT

    Benzocaine 20%

    Menthol 0.25%

    Zinc Chloride 0.15%

  • PURPOSE

    Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

  • 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

    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 small amount of product to the affected area, 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 use if tube tip is cut prior to opening • do not use continuously • Cream will stay in place for extended duration of relief.

  • INACTIVE INGREDIENT

    cellulose gum, chamomile, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene glycol, sodium saccharin

  • QUESTIONS

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

  • INDICATIONS & USAGE

    Use • for the temporary relief of oral pain due to minor irritation or injury of the mouth and gums

  • PRINCIPAL DISPLAY PANEL

    #1

    Oral Pain

    Reliever Brand

    For Toothache

    New Formula!

    3x More

    Acitve Ingredients*

    Orajel

    Instant Pain Relief

    Severe PM

    Toothache & Gum Relief Plus

    Triple Medicated

    Nighttime Formula with Chamomile

    20% Benzocaine to Relieve Oral Pain

    Astringent to Relieve Gum Irritation NEW

    Menthol to Soothe Gums

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

    Long-Lasting

    Cream

    OJFC-31854-10 (2).jpg

    OJFC-31854-10 (2).jpg

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE, MENTHOL, ZINC CHLORIDE 
    orajel severe pm toothache and gum relief cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GELATIN (UNII: 2G86QN327L)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PECTIN (UNII: 89NA02M4RX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-771-251 in 1 CARTON04/27/201712/17/2021
    17 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 finalpart35604/27/201712/17/2021
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-771)