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 Daxal Cosmetics Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

DRUG FACTS

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.

INACTIVE INGREDIENTS

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

DIRECTIONS:

Adults & Children 6 years of age & older : Brush teeth throughly, 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.

PRINCIPAL DISPLAY PANEL - 43 g Tube

INGREDIENTS AND APPEARANCE

NATURE MINT ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76001-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76001-001-01	7.94 g in 1 PACKET; Type 0: Not a Combination Product	01/01/2018
2	NDC: 76001-001-02	17 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 76001-001-03	24 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
4	NDC: 76001-001-04	43 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
5	NDC: 76001-001-05	78 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
6	NDC: 76001-001-07	1 in 1 CARTON	01/01/2018
6		181 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 76001-001-06	1 in 1 CARTON	01/01/2018
7		130 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	01/01/2018

Labeler - Daxal Cosmetics Private Limited (650497790)

Establishment
Name	Address	ID/FEI	Business Operations
Daxal Cosmetics Private Limited		650497790	manufacture(76001-001)