Label: GIANT EAGLE ORIGINAL ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

  • 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 September 12, 2019

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  • Active ingredients

    Eucalyptol 0.092%

    Menthol 0.042%

    Methyl Salicylate 0.060%

    Thymol 0.064%

    Purpose

    Antiplaque/Antigingivitis

  • Uses

    helps reduce plaque that leads to

    • gingivitis
    • bleeding gums
  • Warnings

    Stop use and ask a dentist if 

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    • Children 6 years to under 12 years of age: supervise use.
    • Children under 6 years of age: do not use.
  • Other information

    • this rinse is not intended to replace brushing or flossing
    • store at room temperature. Cold weather may cloud this product, its antiseptic properties are not affected
  • Inactive ingredients

    Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

  • Label copy

    image of the label

  • INGREDIENTS AND APPEARANCE
    GIANT EAGLE ORIGINAL ANTISEPTIC 
    eucalyptol, menthol, methyl salicylate, thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-018
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-018-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/11/2019
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-018)
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