Colgate®

Colgate®
SPL v3
SPL
SPL Set ID 0e2ae43e-54a8-41fd-828b-448623c631f1
Route
DENTAL
Published
Effective Date 2019-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg) Nitrate Ion (50 mg)
Inactive Ingredients
Water Hydrated Silica Glycerin Sorbitol Polyethylene Glycol 600 Potassium Pyrophosphate Butyl Ester Of Methyl Vinyl Ether/maleic Anhydride Copolymer (125000 Mw) Sodium Lauryl Sulfate Poloxamer 407 Sodium Hydroxide Saccharin Sodium Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-12-18 Until 2015-12-31

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities
Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50566-9

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.

Section 50567-7

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

Section 55105-1
Active ingredients Purpose
Potassium nitrate 5% Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion) Anticavity
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 physician
Questions?

1-800-468-6502

Inactive Ingredients

water, hydrated silica, glycerin, sorbitol, PEG-12, tetrapotassium pyrophosphate, PVM/MA copolymer, flavor, sodium lauryl sulfate, poloxamer 407, sodium hydroxide, sodium saccharin, cellulose gum, xanthan gum, titanium dioxide

Principal Display Panel 170 G Tube Carton

Colgate ®

Toothpaste for Sensitive Teeth and Cavity Protection

8 Benefits

✓Sensitivity    ✓Tartar    ✓Freshens

✓Enamel      ✓Plaque** ✓Whitens

✓Cavities    ✓Gums**

NET WT 6.0 OZ (170 g)

NEW

MAXIMUM STRENGTH*

Sensitive

Complete Protection


Structured Label Content

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
Potassium nitrate 5% Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion) Anticavity
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 physician
Questions?

1-800-468-6502

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, glycerin, sorbitol, PEG-12, tetrapotassium pyrophosphate, PVM/MA copolymer, flavor, sodium lauryl sulfate, poloxamer 407, sodium hydroxide, sodium saccharin, cellulose gum, xanthan gum, titanium dioxide

Principal Display Panel 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

Colgate ®

Toothpaste for Sensitive Teeth and Cavity Protection

8 Benefits

✓Sensitivity    ✓Tartar    ✓Freshens

✓Enamel      ✓Plaque** ✓Whitens

✓Cavities    ✓Gums**

NET WT 6.0 OZ (170 g)

NEW

MAXIMUM STRENGTH*

Sensitive

Complete Protection


Advanced Ingredient Data


Raw Label Data

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