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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)
Available from:
Nutralife Biosciences, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps prevent and reduce: - plaque - gingivitis
Authorization status:
OTC monograph not final
Authorization number:
73761-104-02

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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 ingredients

Purposes

Eucalyptol 0.092% }

Menthol 0.042% }

Methyl salicylate 0.060% }

Thymol 0.064% }

Antiplaque/antigingivitis

Us es

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

MOUTH ORAL SHIELD

eucalyptol, menthol, methyl salicylate, and thymol spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7376 1-10 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EUCALYPTO L (UNII: RV6 J6 6 0 4TK) (EUCALYPTOL - UNII:RV6 J6 6 0 4TK)

EUCALYPTOL

0 .9 2 mg in 1 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .42 mg in 1 mL

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .6 mg in 1 mL

THYMO L (UNII: 3J50 XA376 E) (THYMOL - UNII:3J50 XA376 E)

THYMOL

0 .6 4 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BETADEX (UNII: JV0 39 JZZ3A)

ASCO RBIC ACID (UNII: PQ6 CK8 PD0 R)

ZINC CHLO RIDE (UNII: 8 6 Q357L16 B)

PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

XYLITO L (UNII: VCQ0 0 6 KQ1E)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7376 1-10 4-0 2

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

12/0 1/20 20

Nutralife Biosciences, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

12/0 1/20 20

Labeler -

Nutralife Biosciences, Inc. (078834338)

Revised: 12/2020

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