Label: AQUA BLUE MOUTHWASH- methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid

  • 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 February 27, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Eucalyptol 0.092%Antiplaque/Antigingivitis
    Menthol 0.042%Antiplaque/Antigingivitis
    Methyl Salicylate 0.060%Antiplaque/Antigingivitis
    Thymol 0.064%Antiplaque/Antigingivitis
  • Use

    helps control plaque that leads to gingivitis

  • Warnings

    Do not use if you have painful or swollen gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontis, 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

    • do not swallow
    • not intended to replace brushing or flossing.
    Adults and children 12 years of age and olderVigorously swish 20mL between teeth twice a day for 30 seconds then spit out.
    children under 12 years of ageconsult a dentist or doctor
  • Other information

    Store at room temperature (59°-77°F).

  • Inactive ingredients

    Water,Alcohol (21.6%),Polysorbate 80,Sorbitol,Flavor,Benzoic Acid,Sodium Saccharin,Sodium Benzoate,Blue 1,Yellow 5

  • PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label

    BodyOne
    Products

    AQUA ⚬ BLUE

    MOUTH WASH

    1 U.S. Gallon (128 FL.OZ.)

    PRINCIPAL DISPLAY PANEL - 128 FL.OZ. Jug Label
  • INGREDIENTS AND APPEARANCE
    AQUA BLUE MOUTHWASH 
    methyl salicylate, menthol, unspecified form, eucalyptol, and thymol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73563-022
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl Salicylate0.6 mg  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.42 mg  in 1 mL
    Eucalyptol (UNII: RV6J6604TK) (Eucalyptol - UNII:RV6J6604TK) Eucalyptol0.92 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) 216 mg  in 1 mL
    SORBITOL (UNII: 506T60A25R)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73563-022-013785 mL in 1 JUG; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35602/01/2020
    Labeler - Body One Products Inc (117376115)
    Registrant - BMC 1092,Inc dba Solo Laboratories, Inc (078831987)
    Establishment
    NameAddressID/FEIBusiness Operations
    BMC 1092,Inc dba Solo Laboratories, Inc078831987MANUFACTURE(73563-022)
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