Label: BENZOCAINE, MENTHOL, ZINC CHLORIDE- orajel instant pain relief severe cream

  • NDC Code(s): 10237-768-25, 10237-768-33
  • 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

    Benzocaine - Oral Pain Reliever

    Menthol - Oral Pain Reliever

    Zinc Chloride - Oral Astringent

  • INDICATIONS & USAGE

    Use • or 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 if 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

    Inactive Ingredients • cellulose gum, gelatin, methyl salicylate, mineral oil, pectin, petrolatum, polyethylene, glycol, sodium saccharin, water

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    #1

    ORAL PAIN

    RELIEVER BRAND

    FOR TOOTHACHE

    New Formula!

    3X MORE

    Active Ingredients*

    Orajel™

    Instant Pain Relief

    SEVERE

    Toothache & Gum Relief Plus

    TRIPLE MEDICATED

    • 20% Benzocaine to Relieve Oral Pain

    • Astringent to Relieve Gum Irritation NEW

    • Menthol to soothe gums

    LONG-LASTING

    CREAM

    Oral Pain Reliever/Astringent

    NET WT 0.33 OZ (9.4g)

    OJFC-32501-09_CREAM

  • INGREDIENTS AND APPEARANCE
    BENZOCAINE, MENTHOL, ZINC CHLORIDE 
    orajel instant pain relief severe cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-768
    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) MENTHOL2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GELATIN (UNII: 2G86QN327L)  
    PECTIN (UNII: 89NA02M4RX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-768-331 in 1 CARTON02/20/201712/17/2021
    19.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:10237-768-251 in 1 CARTON02/20/201712/17/2021
    27 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 finalpart35602/20/201712/17/2021
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc.043690812manufacture(10237-768)