Colgate®

Colgate®
SPL v1
SPL
SPL Set ID f065318c-1e2a-c04d-f254-f8127b05a88f
Route
DENTAL
Published
Effective Date 2025-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Glycerin Sodium Pyrophosphate Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Potassium Nitrate Saccharin Sodium Xanthan Gum Cocamidopropyl Betaine Titanium Dioxide D&c Red No. 30

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-26

Description

Drug Facts

Purpose

Anticavity, Antigingivitis, Antisensitivity


Medication Information

Purpose

Anticavity, Antigingivitis, Antisensitivity

Description

Drug Facts

Uses
  • aids in the prevention of cavities
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • helps prevent gingivitis
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 sensitivity 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 for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Purposes

Anticavity, Antigingivitis, Antisensitivity

Directions
  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.
Questions?

1-800-468-6502

Active Ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.
Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Flavor, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, Red 30, Titanium Dioxide.

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Principal Display Panel 85 G Tube Carton

Colgate®

Anticavity, Antigingivitis and Antisensitivity Toothpaste

Total

ACTIVE PREVENTION

NET WT 3.0 OZ (85 g)

GENTLE MINT

PASTE

CLINICALLY

PROVEN

ANTIBACTERIAL

24

HOUR1

✓ Gingivitis ✓ Plaque ✓ Tartar ✓ Sensitivity

✓ Weak Enamel ✓ Stains ✓ Bad Breath ✓ Cavities

Sensitivity

Mineral

Shield

Helps Prevent

Sensitivity

from Day 1*


Structured Label Content

Uses
  • aids in the prevention of cavities
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • helps prevent gingivitis
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 sensitivity 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 for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Purposes

Anticavity, Antigingivitis, Antisensitivity

Directions
  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Other Information (Other information)
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.
Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, Glycerin, Flavor, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, Red 30, Titanium Dioxide.

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Colgate®

Anticavity, Antigingivitis and Antisensitivity Toothpaste

Total

ACTIVE PREVENTION

NET WT 3.0 OZ (85 g)

GENTLE MINT

PASTE

CLINICALLY

PROVEN

ANTIBACTERIAL

24

HOUR1

✓ Gingivitis ✓ Plaque ✓ Tartar ✓ Sensitivity

✓ Weak Enamel ✓ Stains ✓ Bad Breath ✓ Cavities

Sensitivity

Mineral

Shield

Helps Prevent

Sensitivity

from Day 1*


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)