MOUTH ORAL SHIELD- eucalyptol, menthol, methyl salicylate, and thymol spray 
Nutralife Biosciences, Inc.

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.

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Mouth Oral Shield Spray

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:

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

Directions

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

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)

Revised: 12/2020
Document Id: b5e317db-0117-6698-e053-2a95a90aa657
Set id: b5e317c8-4c1b-1af9-e053-2a95a90a8a91
Version: 1
Effective Time: 20201207
 
Nutralife Biosciences, Inc.