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 Solventum US OpCo LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium fluoride 0.21% (0.12% w/v fluoride ion)

Purpose

Anticavity Toothpaste

Use

Helps protect teeth and roots against cavities

Warnings

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
• do not swallow
• to minimize swallowing, use a pea-sized amount in children under 6
• supervise children's brushing until good habits are established
• children under 2 years: ask a dentist

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

Questions? 1-800-634-2249

Principal Display Panel - 57g Carton Label

3M ESPE

Clinpro™ Tooth Crème

Spearmint

0.21% Sodium FlourideAnti-Cavity Toothpaste

Contents: 1 Tube NET WT 2 oz (57 g)

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

Spearmint

Principal Display Panel - 24g Tube Label

3M ESPE

Clinpro™ Tooth Creme

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

24g

Spearmint

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

Spearmint

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

Spearmint

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

Spearmint

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

Spearmint

INGREDIENTS AND APPEARANCE

CLINPRO TOOTH CREME 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48878-3170
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	SPEARMINT (SPEARMINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48878-3170-1	1 in 1 BOX	12/20/2010
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 48878-3170-2	1 in 1 BOX	12/20/2010
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 48878-3170-5	1 in 1 BOX	12/20/2013
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
Sheffield Pharmaceuticals LLC		151177797	manufacture(48878-3170)