Label: ANTISEPTIC MOUTHRINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 67860-072-69, 67860-072-86
  • Packager: Cariba International
  • 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 27, 2023

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

  • Active ingredients

    Eucalyptol 0.092%, Menthol 0.042%, Methyl sailcylate 0.060%, Thymol 0.064%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    Helps control plaque that leads to gingivitis

  • Warnings

    for this product

  • Do not use

    if you have painful or swollen gums, pus from the gum line, loose teeth or incresed spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

  • Stop use and ask a dentist if

    gingivitis, bleeding, or rednss persists for more than 2 weeks

  • 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

    • do not swallow  - not intended to replace brushing or flossing

    adults and and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonful) between teeth twice a day for 30 seconds then spit out
    children under 12 years of age -  consult a dentist or doctor

  • Other information

    cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59° -77°F)

  • Inactive ingredients

    water, alcohol 21.6 %, sorbitol solution, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, D&C yellow no. 10, FD7C green no.3

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Cariba International

    P.O. Box 1208

    Safety Harbor, Florida 34695

    MADE IN USA WITH US AND FOREIGN COMPONENTS

  • Principal display panel

    Sealed with Printed Neckband for your Protection

    CARIBA CARE

    ANTISEPTIC

    Mouthwash

    ANTIGINGIVITIS/ANTIPLAQUE

    FRESH MINT

    Kills germs that cause bad breath, plaque & the gum disease gingivitis

    250 mL (8.5 FL OZ)

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC MOUTHRINSE 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67860-072
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67860-072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/18/2016
    2NDC:67860-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/18/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/18/2016
    Labeler - Cariba International (049354067)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(67860-072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(67860-072)