SAFETYMAXX MINT FLAVOR- sodium monofluorophosphate paste, dentifrice

SafetyMAXX Mint Flavor by

Drug Labeling and Warnings

SafetyMAXX Mint Flavor by is a Otc medication manufactured, distributed, or labeled by FSi, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Monofluorophosphate - 0.76% (Total fluoride content - 1000ppm Approx)

Purpose

Anticavity

Use:

Helps protect against cavities

Warnings

If more than used for brushing is swallowed, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children under 6years of age.

Directions

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.

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, methylparaben, Titanium Dioxide, Polyethylene Glycol 400 Propyl Paraben

SPL UNCLASSIFIED SECTION

Product of China, Exclusively produced for FSi, Inc. 1-800-647-5923 www.myfsi.net Expires 2 years from the DAte of Mfg

FSi, Inc Nashville TN 37210

Product Tube Label

INGREDIENTS AND APPEARANCE

SAFETYMAXX MINT FLAVOR 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60371-339
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM DIHYDRATE (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: 60371-339-06	17 g in 1 TUBE
2	NDC: 60371-339-85	24 g in 1 TUBE
3	NDC: 60371-339-15	43 g in 1 TUBE
4	NDC: 60371-339-27	78 g in 1 TUBE
5	NDC: 60371-339-46	130 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/15/2011

Labeler - FSi, Inc. (609296694)