Freshmint Premium Anticavity (Sodium Fluoride) Paste, Dentifrice [New World Imports, Inc] -

FRESHMINT PREMIUM ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [NEW WORLD IMPORTS, INC]
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OTC Active Ingredient

Sodium Fluoride - 0.243% (0.15 w/v fluoride ion)
OTC Purpose

Anticavity
Keep out of reach of Children under 6 years of age

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Uses

Helps protect teeth and roots against cavities.
Warnings

Keep out of reach of children under 6 years of age. if you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.
Directions
Adults and children 2 years & older:
- Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
- Do not swallow.
- To minimize swallowing use a pea-sized amount in children under 6 years of age.
- Supervise children's brushing until good habits are established.
Children under 2 years:
- Ask a dentist
Inactive Ingredients

Sorbitol, Silica, Treated Water (aqua), Glycerin, Polyethulene Glycol 1500, Sodium Lauryl Sulphate, Flavor, Titanium Dioxide, Cellulose Gum, Carrageenan, Trisodium Orthophosphate, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Methylparaben, Propylparaben, Color: FD&C Blue #1
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRESHMINT PREMIUM ANTICAVITY
sodium fluoride paste, dentifrice

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.43 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
Sodium benzoate (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51824-029-02	144 in 1 CARTON	01/01/2013
1	NDC:51824-029-01	24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:51824-029-05	144 in 1 CARTON	01/01/2013
2	NDC:51824-029-04	36 in 1 BOX
2	NDC:51824-029-03	43 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:51824-029-07	72 in 1 CARTON	01/01/2013
3	NDC:51824-029-06	85 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	01/01/2013

Labeler - New World Imports, Inc (075372276)

Registrant - New World Imports, Inc (075372276)

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