Label: ORAL7 DRY MOUTH MOISTURIZING- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 81175-000-02 - Packager: Oral7 USA Operations Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 14, 2021
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- Drug Facts
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Adults and Children 2 years of age and older
- Use 2-3 times a day, 7 days a week.
- Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a doctor or dentist.
- Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
- Other Information
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Inactive ingredients
DICALCIUM PHOSPHATE, HYDROGENATED STARCH HYDROLYSATE, GLYCERIN, AQUA, SILICA, DEXTROSE MONOHYDRATE, HYDRATED SILICA, ISOCETETH-20, XYLITOL, SODIUM MONOFLUOROPHOSPHATE, XANTHAN GUM, MENTHA PIPERITA (PEPPERMINT OIL), SODIUM BENZOATE, LACTOPEROXIDASE, POTASSIUM THIOCYANATE, LACTOFERRIN, LYSOZYME, GLUCOSE OXIDASE, LIMONENE, CALCIUM LACTATE
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INGREDIENTS AND APPEARANCE
ORAL7 DRY MOUTH MOISTURIZING
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81175-000 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength XANTHAN GUM (UNII: TTV12P4NEE) LACTOFERRIN, BOVINE (UNII: KG21X1090A) LIMONENE, (+)- (UNII: GFD7C86Q1W) HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) DEXTROSE MONOHYDRATE (UNII: LX22YL083G) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISOCETETH-20 (UNII: O020065R7Z) XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) MYELOPEROXIDASE (UNII: JQZ6YM58U5) MENTHA PIPERITA (UNII: 79M2M2UDA9) POTASSIUM THIOCYANATE (UNII: TM7213864A) LYSOZYME (UNII: 968JKA7T33) GLUCOSE OXIDASE (UNII: 0T8392U5N1) CALCIUM LACTATE (UNII: 2URQ2N32W3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81175-000-02 75 mL in 1 TUBE; Type 0: Not a Combination Product 06/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/01/2019 Labeler - Oral7 USA Operations Inc (117789267)