LUCKY SUPER SOFT WHITENING ANTI CAVITY- 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

Use

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, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPER SOFT  WHITENING ANTI CAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-553
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
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-553-01	2 in 1 BOX	03/31/2017
1	NDC: 20276-553-04	113 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	03/31/2017

Labeler - Delta Brands Inc (102672008)