Label: MOUTH ORAL SHIELD- eucalyptol, menthol, methyl salicylate, and thymol spray
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Contains inactivated NDC Code(s)
NDC Code(s): 73761-104-02 - Packager: Nutralife Biosciences, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 7, 2020
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- ACTIVE INGREDIENT
- Uses
- Warnings
- Other information
- Directions
- Inactive ingredients
- Mouth Oral Shield Spray
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INGREDIENTS AND APPEARANCE
MOUTH ORAL SHIELD
eucalyptol, menthol, methyl salicylate, and thymol sprayProduct 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)