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

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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)

Commercializzato da:

Nutralife Biosciences, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

OTC DRUG

Indicazioni terapeutiche:

Helps prevent and reduce: - plaque - gingivitis

Stato dell'autorizzazione:

OTC monograph not final

Scheda tecnica

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 TAS