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

Mouth Oral Shield by

Drug Labeling and Warnings

Mouth Oral Shield by is a Otc medication manufactured, distributed, or labeled by Nutralife Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Active ingredients	Purposes
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

INGREDIENTS AND APPEARANCE

MOUTH ORAL SHIELD 
eucalyptol, menthol, methyl salicylate, and thymol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73761-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73761-104-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/01/2020

Labeler - Nutralife Biosciences, Inc. (078834338)