LUCKY SUPER SOFT ANTI CAVITY WITH FREE TOOTHBRUSH- sodium monofluorophosphate paste, dentifrice

Lucky Super Soft by

Drug Labeling and Warnings

Lucky Super Soft by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Purpose

Anticavity

Uses

Regular brushing with fluoride tothpaste helps protect against cavities

Keep out of the reach of children

under 6 years of age

Warnings

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Directions

adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

Inactive ingredients

calcium carbonate, flavor, methyl paraben, polyethylene glycol 400, precipitated silica,  propyl paraben, sodium carboxymethyl cellulose,  sodium lauryl sulphate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPER SOFT  ANTI CAVITY WITH FREE TOOTHBRUSH
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-551
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)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-551-64	181 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	02/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/27/2014

Labeler - Delta Brands Inc (102672008)