Label: ORAL7- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 69297-000-19 - Packager: JCEC Company, 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 January 8, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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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Ingredients
Sorbitol, Dicalcium Phosphate, Glycerin, Hydrated Silica, Dextrose Monohydrate, Silica, Isoceteth-20, Xylitol, Water, Cellulose Gum, Sodium Benzoate, Lactoperoxidase , Mentha Piperita (Peppermint Oil-includes limonene), Potassium Thiocyanate, Menthol, Lactoferrin , Lysozyme, Glucose Oxidase, Calcium Lactate
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PRINCIPAL DISPLAY PANEL - 105 g Tube Carton
NDC 69297-000-19
Oral 7®Xylitol
balancing your mouth's natural floraBeneficial for the
whole family!- ✓
- No SLS (harsh drying detergent)
- ✓
- With Fluoride & Calcium
- ✓
- Extra Beneficial for Dry Mouth
MOISTURIZING
TOOTHPASTEWith natural enzymes to
help reinforce your
mouth's own defense system75mL (105g) e
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INGREDIENTS AND APPEARANCE
ORAL7
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69297-000 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (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) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM BENZOATE (UNII: OJ245FE5EU) MYELOPEROXIDASE (UNII: JQZ6YM58U5) MENTHA PIPERITA (UNII: 79M2M2UDA9) POTASSIUM THIOCYANATE (UNII: TM7213864A) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) LACTOFERRIN, BOVINE (UNII: KG21X1090A) LYSOZYME (UNII: 968JKA7T33) GLUCOSE OXIDASE (UNII: 0T8392U5N1) CALCIUM LACTATE (UNII: 2URQ2N32W3) Product Characteristics Color WHITE (TO OFF WHITE) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69297-000-19 1 in 1 CARTON 1 105 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 02/01/2015 Labeler - JCEC Company, Inc. (961973299)