Label: ORAL SORE ANTISEPTIC- hydrogen peroxide, menthol liquid

  • NDC Code(s): 72476-024-43
  • Packager: RETAIL BUSINESS SERVICES , LLC
  • 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 April 21, 2023

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

  • Active ingredients

    Hydrogen peroxide 1.5% (w/v)

    Menthol 0.1% (w/v)

  • Purpose

    Oral debriding agent/Oral antiseptic
    Oral pain reliever

  • Uses

    ▪ first aid to help protect against bacterial contamination in minor oral wounds


    ▪ for temporary pain relief and ▪ temporary use in cleansing minor wounds or
    minor gum inflammation resulting from: ▪ minor dental procedures ▪ dentures
    ▪ orthodontic appliances ▪ accidental injury ▪ other irritations of the mouth
    and gums ▪ canker sores


    ▪ aids in the removal of: ▪ phlegm ▪ mucus ▪ other secretions associated with
    occasional sore mouth

  • Warnings

    for this product

  • Stop use and ask a doctor if

    ▪ sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting
    ▪ irritation, pain, or redness persists or worsens
    ▪ swelling, rash, or fever develops
    ▪ sore mouth symptoms do not improve in 7 days

  • When using this product

    •  do not swallow 
    •  do not use more than 7 days unless directed by a dentist or doctor 
    •  do not exceed recommended dosage
  • 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

    Adults and children 2 years of age and older - swish two teaspoons (10 mL) around the mouth for at least 1 minute, then spit out; use up to 4 times daily or as directed by a dentist or physician

    Children under 12 years of age - should be supervised in the use of the product

    Children under 2 years of age - consult a dentist or doctor

  • Other information

    • store at controlled room temperature 68-77°F (20-25°C) 
    • keep away from heat or direct sunlight
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY ADUSA DISTRIBUTION, LLC

    SALISBURY, NC 28147

    For product questions or concerns,

    contact us at 1-833-992-3872

    Quality guarenteed or your money back.

    *This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of Orajel Antiseptic Rinse Mouth Sores.

    DSP-TN-21091   DSP-MO-20087

  • Principal display panel

    CAREONE

    Compare to Orajel Antispetic Rinse Mouth Sores*

    ORAL SORE

    ANTISEPTIC RINSE

    ORAL PAIN RELIEVER

    ORAL DEBRIDING AGENT

    FOR MOUTH SORES, INCLUDING GUM IRRITATIONS FROM BRACES OR DENTURES AND CANKER SORES

    MINT FLAVOR

    Sealed With Printed Neckband For Your Protection

    NET 16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ORAL SORE ANTISEPTIC 
    hydrogen peroxide, menthol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-024
    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 (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-024-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/13/2023
    Labeler - RETAIL BUSINESS SERVICES , LLC (967989935)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    VI-Jon, LLC790752542manufacture(72476-024)
    Establishment
    NameAddressID/FEIBusiness Operations
    VI-Jon, LLC088520668manufacture(72476-024)