CLINPRO TOOTH CREME- sodium fluoride paste, dentifrice

Clinpro Tooth Creme by

Drug Labeling and Warnings

Clinpro Tooth Creme by is a Otc medication manufactured, distributed, or labeled by 3M ESPE Dental Products, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Principal Display Panel - 24g Carton Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate

24g

Vanilla Mint

Principal Display Panel - Tube Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate

24g

Vanilla Mint

Principal Display Panel - 90 mL Carton Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

90 ml

Vanilla Mint

Principal Display Panel - 90 mL Tube Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

90 ml

Vanilla Mint

Principal Display Panel - 113g Carton Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate

113g

Vanilla Mint

Principal Display Panel - 113g Tube Label

3M ESPE

Clinpro™ Tooth Creme

0.21% w/w Sodium Fuoride Anti-Cavity Paste with Tri-Calcium Phosphate

113g

Vanilla Mint

INGREDIENTS AND APPEARANCE

CLINPRO TOOTH CREME 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48878-3150
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.950 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48878-3150-1	1 in 1 BOX	12/20/2010
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 48878-3150-2	1 in 1 BOX	12/20/2010
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 48878-3150-5	1 in 1 BOX	12/20/2010
3		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
export only		12/20/2010

Labeler - 3M ESPE Dental Products (801390852)

Establishment
Name	Address	ID/FEI	Business Operations
Faria Limited dba Sheffield Pharmaceuticals		151177797	manufacture(48878-3150)