Label: ORAJEL 2X GUM PAIN ALCOHOL-FREE- menthol and hydrogen peroxide rinse

  • NDC Code(s): 10237-799-16
  • 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 January 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Hydrogen peroxide 1.5%Oral debriding agent/Oral antiseptic
    Menthol 0.1%Oral pain reliever
  • Uses

    • first aid to help reduce bacteria in minor oral wounds
    • for temporary pain relief and
    • use in cleansing minor wounds or minor gum inflammation resulting from:
      • minor dental procedures
      • accidental injury
      • orthodontic appliances
      • canker sores
      • dentures
      • other irritations of the mouth and gums

    Aids in the removal of:

    • phlegm
    • mucus
    • other secretions associated with occasional sore mouth
  • Warnings

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

    When using this product do not swallow

    • do not exceed recommended dosage

    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

    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

  • 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 and olderSwish 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 ageShould be supervised in the use of this product
    Children under 2 years of ageConsult 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 ingredients

    disodium EDTA, FD&C blue no.1, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, propylene glycol, sodium saccharin, sorbitol, water

  • Questions or comments?

    call us at 1-800-952-5080 M–F 9am–5pm ET or visit our website at www.orajel.com

  • PRINCIPAL DISPLAY PANEL - 473.2 mL Bottle Label

    1#
    ORAL PAIN
    RELIEF BRAND
    FOR ADULTS

    Orajel™
    2X
    GUM PAIN RINSE
    MEDICATED
    ALCOHOL FREE

    EFFECTIVE ORAL PAIN RELIEF

    ✓
    Soothes & Cools Gums
    ✓
    Kills Harmful Bacteria
    ✓
    Promotes Healing
    ✓
    Relieves Gum Irritation
    Caused by Dentures or Braces

    ORAL DEBRIDING AGENT/
    ANTISEPTIC RINSE/PAIN RELIEVER

    Soothing
    MINT

    16 FL OZ (473.2 mL)

    OJLBF-01904-01 72025286

    Principal Display Panel - 473.2 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ORAJEL 2X GUM PAIN   ALCOHOL-FREE
    menthol and hydrogen peroxide rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-799
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, unspecified form (UNII: L7T10EIP3A) (Menthol, unspecified form - UNII:L7T10EIP3A) Menthol, unspecified form1 mg  in 1 mL
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Poloxamer 338 (UNII: F75JV2T505)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-799-16473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/15/2023
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600MANUFACTURE(10237-799)
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