Nature Mint Anticavity by Bob Barker Company Inc. Nature Mint Anticavity

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]

NATURE MINT ANTICAVITY- sodium monofluorophosphate paste, dentifrice 
Bob Barker Company Inc.

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.

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Nature Mint Anticavity

DRUG FACTS

ACTIVE INGREDIENT

Sodium Monofluorophosphate - 0.76% (Total Fluoride Content - 1000 ppm Approx.)

PURPOSE

Anticavity.

USE

Helps protect against cavities.

WARNINGS

Keep out of 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 physician.
• 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, Purified Water, Sorbitol, Precipitated Silica, Sodium Lauryl Sulphate, Flavor, Sodium Carboxy Methyl Cellulose, Sodium Silicate, Tetra Sodium Pyrophosphate, Sodium Saccharin, Methyl Paraben, Titanium Dioxide, Poly Ethylene Glycol 400, Propyl Paraben.

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Nature Mint
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT. 4.6 OZ (130g)

NATURE MINT ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53247-108
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53247-108-01	7.9 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2008	12/01/2019
2	NDC: 53247-108-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
3	NDC: 53247-108-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
4	NDC: 53247-108-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
5	NDC: 53247-108-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2008	12/01/2019
6	NDC: 53247-108-06	1 in 1 CARTON	01/01/2008	12/01/2019
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 53247-108-07	1 in 1 CARTON	01/01/2008	12/01/2019
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	12/01/2019

Labeler - Bob Barker Company Inc. (058525536)

Revised: 2/2020

Document Id: 9eedecf3-16f9-db30-e053-2a95a90aea50

34390-5

Set id: 6cf2fff1-3e5c-4c64-9e67-7f3924214825

Version: 3

Effective Time: 20200219

 

Bob Barker Company Inc.