Label: MOUTH ORAL SHIELD- eucalyptol, menthol, methyl salicylate, and thymol spray

  • 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 December 7, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Eucalyptol 0.092% Menthol 0.042% Methyl Salicylate 0.060% Thymol 0.064%

    Active ingredientsPurposes
    Eucalyptol 0.092% }

    Menthol 0.042% }

    Methyl salicylate 0.060% }

    Thymol 0.064% }     		Antiplaque/antigingivitis
  • Uses

    Helps prevent and reduce:

    • plaque
    • gingivitis
  • Warnings

    Do not use

    in children under 12 years of age

    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.

  • Other information

    • Store at room temperature.
    • Cold weather may cloud this product. Its antiseptic properties are not affected
  • Directions

    • Shake well before use
    • Apply 2 sprays directly into mouth
    • Use up to 3 times daily
  • Inactive ingredients

    Water, Alcohol (21.6%), Xylitol, Poloxamer 407, Vitamin C Citrus Bioflavonoid Complex, Mint Flavor, Sucralose, Potassium Sorbate, Zinc Chloride, Beta Cyclodextrin, FD&C Green 3

  • Mouth Oral Shield Spray

    label

  • INGREDIENTS AND APPEARANCE
    MOUTH ORAL SHIELD 
    eucalyptol, menthol, methyl salicylate, and thymol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73761-104
    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 SALICYLATE0.6 mg  in 1 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BETADEX (UNII: JV039JZZ3A)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73761-104-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/01/2020
    Labeler - Nutralife Biosciences, Inc. (078834338)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!