DOLLAR GENERAL MAXIMUM STRENGTH- fluoride paste, dentifrice

Dollar General by

Drug Labeling and Warnings

Dollar General by is a Otc medication manufactured, distributed, or labeled by Dolgencorp LLC, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

PURPOSE

Purpose

Antisensitivity

Anticavity

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

Wnen using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

See your dentist if the problem 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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush.

• Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican.
• Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: consult a dentist or a doctor.

INACTIVE INGREDIENT

Inactive ingredients D&C yellow #10, FD& C blue #1, flavor, glycerin, hydrated silica, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, trisodium phosphate, water, xanthan gum

STORAGE AND HANDLING

Store in a cool dry place. Keep tube capped when not in use.

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

MADE IN U.S.A.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLLAR GENERAL  MAXIMUM STRENGTH
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-320
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-320-39	1 in 1 CARTON	01/20/2011
1		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 not final	part356	01/20/2011

Labeler - Dolgencorp LLC (068331990)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(55910-320)