LUCKY SUPER SOFT SENSITIVE- sodium fluoride potassium nitrate 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

Potassium nitrate - 5%

Sodium fluoride - 0.24%

Purpose

Antihypersensitivity

Anticavity

Uses

■ builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact ■ aids in the prevention of dental cavities

Warnings

When using this product ■ if pain/sensitivity still persists after 4 weeks of use please visit your dentist

Stop and ask a dentist

■ if problem the persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

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

Directions

adults and children 12 years and older brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist. Be sure to brush sensitive areas

children under 12 years of age consult a dentist or doctor.

Inactive ingredients

DC Yellow10, FDC Blue 1, flavor, glycerin, methylparaben, poly ethylene glycol 1500, propylparaben, silica, sodium benzoate, sodium carboxy methyl cellulose, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho phosphate

Package Label

INGREDIENTS AND APPEARANCE

LUCKY SUPER SOFT  SENSITIVE
sodium fluoride potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-550
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)
WATER (UNII: 059QF0KO0R)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-550-43	122 g in 1 TUBE; Type 0: Not a Combination Product	02/27/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/27/2014

Labeler - Delta Brands Inc (102672008)