Label: ORAJEL TOOTHACHE RINSE- benzyl alcohol, zinc chloride liquid

  • NDC Code(s): 10237-764-08, 10237-764-16
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2024

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

  • ACTIVE INGREDIENT

    Benzyl Alcohol 0.27%

    Zinc Chloride 0.15%

  • PURPOSE

    Oral pain reliever

    Oral astringent

  • INDICATIONS & USAGE

    Usefor temporary relief of pain due to toothaches, minor irritation of the mouth and gums, occasional minor irritation, pain, sore mouth and sore throat

  • WARNINGS

    Warnings

    Do not usethis product for more than 7 days unless directed by a dentist or healthcare provider

  • WHEN USING

    When using this product• do not swallow • do not exceed recommended dosage

  • STOP USE

    Stop use and see your physician promptly if• swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days • allergic reaction occurs • sore thoat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    remove imprinted safety seal from bottle cap

    • to remove child-resistant cap, squeeze smooth sides of cap while turning. Reclose tightly. Ready to use, no mixing needed.

    Adults and children 2 years of age or over:

    Swish one-half capful (2 teaspoons = 10mL) around the mouth over the affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or healthcare provider

    Children under 12 years of age:

    Should be supervised in the use of this product

    Children under 2 years of age:

    Consult a dentist or healthcare provider

    Other Information •cap tightly • keep away from heat or direct sunlight • do not use if safety seal is broken or missing

  • INACTIVE INGREDIENT

    Inactive Ingredientsalcohol (4.1% by volume), blue 1, disodium pyrophosphate, menthol, methyl salicylate, poloxamer 338, polysorbate 20, sodium benzoate, sodium saccharin, sorbitol, tetrasodium pyrophosphate, water

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    #1

    ORAL PAIN RELIEVER

    BRAND FOR TOOTHACHE

    NON-NUMBING RELIEF!

    Orajel™

    For TOOTHACHE

    Analgesic & Astringent Rinse

    Provides All-Over Oral Pain Relief

    Soothes Irritated Gums

    Cleans Affected Area

    Kills Odor-Causing Bacteria

    Soothing

    Mint

    Rinse

    ORAL PAIN RELIEVER/

    ASTRINGENT

    16 FL OZ (473.2 mL)

    DA2011186_OJLBF-43001-02_72013520

  • INGREDIENTS AND APPEARANCE
    ORAJEL TOOTHACHE RINSE 
    benzyl alcohol, zinc chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-764
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL2.7 mg  in 1 mL
    ZINC CHLORIDE (UNII: 86Q357L16B) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CALCIUM DISODIUM PYROPHOSPHATE (UNII: T9L63LWS5A)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-764-16473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2016
    2NDC:10237-764-08236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/01/2016
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Co., Inc253933600manufacture(10237-764)