Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
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)
Nutralife Biosciences, Inc.
ORAL
OTC DRUG
Helps prevent and reduce: - plaque - gingivitis
OTC monograph not final
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._ ---------- 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 Прочитать полный документ