Colgate®

Colgate®
SPL v13
SPL
SPL Set ID abfbcacd-9c1a-4472-9e91-a85e78050a9e
Route
DENTAL
Published
Effective Date 2023-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol 600 Sodium Pyrophosphate Sodium Lauryl Sulfate Microcrystalline Cellulose Sodium Citrate, Unspecified Form Zinc Phosphate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Cocamidopropyl Betaine Xanthan Gum Anhydrous Citric Acid Sucralose Mica Titanium Dioxide Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-11-01 Until 2026-12-31

Description

Drug Facts

Purpose

Anticavity, Antigingivitis, Antisensitivity


Medication Information

Purpose

Anticavity, Antigingivitis, Antisensitivity

Description

Drug Facts

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • 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
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

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Mica, Sucralose, Blue 1, Titanium Dioxide, Yellow 10.

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 170 G Tube Carton

Colgate®

Anticavity, Antigingivitis and Antisensitivity Toothpaste

ADA

Accepted

American

Dental

Association ®

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL

✓TARTAR ✓FRESH BREATH ✓WHITENS ✓SENSITIVITY RELIEF

Total

24

HR

ANTIBACTERIAL

PROTECTION

FRESH

MINT STRIPE

NET WT 6.0 OZ (170 g)

GEL


Structured Label Content

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • 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
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)

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Mica, Sucralose, Blue 1, Titanium Dioxide, Yellow 10.

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 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

Colgate®

Anticavity, Antigingivitis and Antisensitivity Toothpaste

ADA

Accepted

American

Dental

Association ®

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL

✓TARTAR ✓FRESH BREATH ✓WHITENS ✓SENSITIVITY RELIEF

Total

24

HR

ANTIBACTERIAL

PROTECTION

FRESH

MINT STRIPE

NET WT 6.0 OZ (170 g)

GEL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)