Label: ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES- hydrogen peroxide and menthol liquid

  • NDC Code(s): 10237-760-16, 10237-760-48
  • 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 10, 2023

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  • ACTIVE INGREDIENT

    Hydrogen peroxide 1.5%

    Menthol 0.1%

  • PURPOSE

    Oral debriding agent/Oral antiseptic

    Oral pain reliever

  • INDICATIONS & USAGE

    • 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

    When using this product do not swallow

    do not exceed recommended dosage

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

    Stop use and see your physician promptly if swallowing, 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

  • 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 and older

    		Swish one-half capful (2 tesapoons=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 SAFETY INFORMATION

    Other Information

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

    alcohol (4.1% by volume), blue 1, disodium EDTA, methyl salicylate, phosphoric acid, poloxamer 338, polysorbate 20, sodium saccharin, sorbitol, water

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    #1

    ORAL PAIN

    RELIEVER BRAND

    FOR ADULTS

    With

    PAIN RELIEF!

    Orajel™

    FOR ALL MOUTH SORES

    ANTISEPTIC RINSE

    Canker Sores Cheek Bites Gum Irritation

    Irritation from Dentures or Braces

    Promotes Healing

    Kills Bacteria

    Provides Pain Relief

    SOOTHING

    MINT

    RINSE

    ORAL DEBRIDING AGENT / ANTISEPTIC RINSE / PAIN RELIEVER

    16 FL OZ (473.2 mL)

    DA2011184_OJLBF-32499-06_72013522

    10237-793 Back Label

  • INGREDIENTS AND APPEARANCE
    ORAJEL ANTISEPTIC RINSE FOR ALL MOUTH SORES 
    hydrogen peroxide and menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-760
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    POLOXAMER 338 (UNII: F75JV2T505)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-760-16473.2 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2014
    2NDC:10237-760-481419.5 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35611/01/2014
    Labeler - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    Church & Dwight Canada Corp.253933600MANUFACTURE(10237-760)
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