Colgate®

Colgate®
SPL v1
SPL
SPL Set ID de4904c0-5709-4815-87f3-589a0f1df9e2
Route
DENTAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg) Nitrate Ion (50 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Polyethylene Glycol 600 Sodium Lauryl Sulfate Carboxymethylcellulose Potassium Hydroxide Sodium Pyrophosphate Phosphoric Acid Cocamidopropyl Betaine Benzyl Alcohol Saccharin Sodium Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-25

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 persists after 4 weeks, visit your dentist.

Section 55105-1
Active ingredients Purpose
Potassium Nitrate 5% Antisensitivity
Sodium Fluoride 0.24% (0.15% 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, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Titanium Dioxide.

Principal Display Panel 107 G Tube Carton

Colgate®

Anticavity Toothpaste for Sensitive Teeth

OPTIC

WHITE®

SENSITIVITY

RELIEF

PASTE SOOTHING MINT

REMOVES 1 YEAR

OF STAINS*

WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 g)

ENAMEL SAFE


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 persists after 4 weeks, visit your dentist.

Section 55105-1 (55105-1)
Active ingredients Purpose
Potassium Nitrate 5% Antisensitivity
Sodium Fluoride 0.24% (0.15% 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, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Titanium Dioxide.

Principal Display Panel 107 G Tube Carton (PRINCIPAL DISPLAY PANEL - 107 g Tube Carton)

Colgate®

Anticavity Toothpaste for Sensitive Teeth

OPTIC

WHITE®

SENSITIVITY

RELIEF

PASTE SOOTHING MINT

REMOVES 1 YEAR

OF STAINS*

WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 g)

ENAMEL SAFE


Advanced Ingredient Data


Raw Label Data

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