Label: ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • NDC Code(s): 55910-099-12, 55910-099-69, 55910-099-77
  • Packager: Old East Main CO
  • 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 October 3, 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

    Warnings for this product

  • Do not use

    if you have painful or swollen gums, pus from the gum line, loose teeth or increased 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 redness 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

    adults and children under 12 years if age and older - vigorously swish 20 ml (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then spit out; do not swallow

    children under 12 years of age - consult a dentist or doctor

    • this rinse is not intended to replace brushing or flossing
  • other information

    cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

  • Inactive ingredients

    water, alcohol 21.6 %, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, flavor, sodium citrate, yellow 10, green 3

  • ADVERSE REACTIONS

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

    Since 1903 Rexall is a registered

    trademark of Rexall Sundown, Inc.

    DISTRIBUTED BY OLD EAST MAIN CO.

    100 MISSION RIDGE

    GOOLETTSVILLE, TN 37072

    100% Satisfaction Guaranteed!

    If you're not satisfied with

    this product for any reason,

    please call us so we can make you

    100% satisfied.

    (888) 309-9030

    DSP-TN-21091

    DSP-MO-20087

  • principal display panel

    DG health

    Antiseptic Mouth Rinse

    Frech Mint

    Compare to active ingredients in Listerine

    Kills germs that cause bad breath,

    plaque, and the gum disease gingivitis

    500 mL (16.9 FL OZ)

    image description

  • principal display panel

    Since 1903

    Rexall

    Spring Mint

    Antiseptic Mouthwash

    Antigingivitis/Antiplaque

    Kills 99.9% of germs commonly assoicated with gingivitis
    Fights bad breath
    helps reduce plaque
    ADA

    Accepted

    America Dental Association

    • Helps reduce plaque
    • Helps reduce gingivitis

    500mL (1.05 PT) 16.9 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTISPETIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-099
    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:55910-099-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2004
    2NDC:55910-099-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2004
    3NDC:55910-099-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/19/2004
    Labeler - Old East Main CO (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-099)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-099)