NATURE MINT ANTICAVITY- sodium monofluorophosphate paste, dentifrice

Nature Mint Anticavity by

Drug Labeling and Warnings

Nature Mint Anticavity by is a Otc medication manufactured, distributed, or labeled by Bob Barker Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredient

Sodium Monofluorophosphate - 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity toothpaste

Use

Helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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

Calcium Carbonate, Sorbitol, Water, Sodium Lauryl Sulfate, Silica, Glycerin, Cellulose Gum, Benzalkonium Chloride, Flavor, Sodium Saccharin, PEG 400, Sodium Chloride, Sodium Methylparaben, Menthol, Sodium Propylparaben

SPL UNCLASSIFIED SECTION

Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526

PRINCIPAL DISPLAY PANEL - 43 Gram Tube Label

Nature Mint®

ANTICAVITY FLUORIDE TOOTHPASTE

SODIUM MONOFLUOROPHOSPHATE - 0.76%

FRESH MINT FLAVOR

NET WT 1.5 OZ (43 GRAMS)

INGREDIENTS AND APPEARANCE

NATURE MINT ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53247-129
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)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
Sodium Chloride (UNII: 451W47IQ8X)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53247-129-01	7.94 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008
2	NDC: 53247-129-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
3	NDC: 53247-129-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
4	NDC: 53247-129-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
5	NDC: 53247-129-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008
6	NDC: 53247-129-06	1 in 1 CARTON	01/01/2008
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 53247-129-07	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 drug	M021	01/01/2008

Labeler - Bob Barker Company Inc. (058525536)