Label: NATURE MINT ANTICAVITY- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 53247-111-01, 53247-111-02, 53247-111-03, 53247-111-04, view more53247-111-05, 53247-111-06, 53247-111-07 - Packager: Bob Barker 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 February 26, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
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DIRECTIONS
Adults & Children 6 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years: Ask a dentist or physician. - INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 7.94 GRAM Packet
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INGREDIENTS AND APPEARANCE
NATURE MINT ANTICAVITY
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53247-111 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 g Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) WATER (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Sodium Lauryl Sulfate (UNII: 368GB5141J) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Sodium Benzoate (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53247-111-01 7.94 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2008 2 NDC:53247-111-02 17 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 3 NDC:53247-111-03 24 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 4 NDC:53247-111-04 43 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 5 NDC:53247-111-05 78 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2008 6 NDC:53247-111-06 1 in 1 CARTON 01/01/2008 6 130 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:53247-111-07 1 in 1 CARTON 01/01/2008 7 181 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 01/01/2008 Labeler - Bob Barker Company Inc. (058525536)
