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Colgate

Mission Hills S.A. de C.V.

Colgate Toothpaste for Sensitive Teeth and Cavity Protection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antisensitivity

Anticavity

Colgate Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities

Warnings

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

Stop use and ask a 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 the reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 years consult a dentist or a physician

Inactive ingredients

water, glycerin, hydrated silica, sorbitol, PEG-12, sodium lauryl sulfate, flavor, poloxamer 407, xanthan gum, cellulose gum, sodium saccharin, sodium hydroxide, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico

www.colgatesensitive.com

PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

Colgate

PRINCIPAL DISPLAY PANEL - 4.0 OZ carton

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

Colgate

Colgate

SODIUM FLUORIDE and POTASSIUM NITRATE PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-358
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 1.1 mg
POTASSIUM NITRATE NITRATE ION 50 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
water
sorbitol
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
POLOXAMER 407
CARBOXYMETHYLCELLULOSE SODIUM
saccharin sodium
SODIUM HYDROXIDE
XANTHAN GUM
titanium dioxide
FD&C BLUE NO. 1

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 170 in 1 TUBE
2 56 in 1 TUBE
3 113 in 1 TUBE
4 NDC:65954-358-69 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-07-26


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Be sure to consult your doctor before taking any medication!
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