NATURE MINT ANTI-CAVITY- 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

Anti-cavity

Drug Facts

Active Ingredient

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

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental 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

Do not swallow

Supervise children as necessary until capable of using without supervision
Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a doctor.
Children under 6 years of age: Do not use unless directed by a doctor or dentist.

Inactive Ingredients

Calcium Carbonate, Sorbitol, Purified Water, Precipitated Silica, Sodium Lauryl Sulphate, Sodium Silicate, Flavor, Carboxy Methyl Cellulose, Sodium Saccharin, Titanium Dioxide, Sodium Benzoate.

PRINCIPAL DISPLAY PANEL - 181 g Tube Carton

Nature Mint

ANTICAVITY FLUORIDE TOOTHPASTE

NET WT. 6.4 OZ (181g)

PRINCIPAL DISPLAY PANEL - 181 g Tube Carton

NATURE MINT ANTI-CAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53247-101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM SILICATE (UNII: IJF18F77L3)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53247-101-41	7.94 g in 1 PACKET; Type 0: Not a Combination Product	01/15/2015	12/01/2019
2	NDC:53247-101-42	17 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015	12/01/2019
3	NDC:53247-101-43	24 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015	12/01/2019
4	NDC:53247-101-44	43 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015	12/01/2019
5	NDC:53247-101-45	78 g in 1 TUBE; Type 0: Not a Combination Product	01/15/2015	12/01/2019
6	NDC:53247-101-46	1 in 1 CARTON	01/15/2015	12/01/2019
6		130 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:53247-101-47	1 in 1 CARTON	01/15/2015	12/01/2019
7		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/15/2015	12/01/2019

Labeler - Bob Barker Company Inc. (058525536)

Revised: 2/2020

Document Id: 9eedc58f-5b07-3f82-e053-2995a90adec8

Set id: 1793cd23-44c9-4382-b90f-3a754b437623

Version: 4

Effective Time: 20200219

Bob Barker Company Inc.

Nature Mint Anti-cavity