Colgate®

Colgate®
SPL v7
SPL
SPL Set ID 2092c747-e025-47a9-9e54-731631d3c831
Route
DENTAL
Published
Effective Date 2022-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Glycerin Hydrated Silica Sorbitol Polyethylene Glycol 600 Methyl Vinyl Ether And Maleic Acid Copolymer (1750000 Wamw) Sodium Lauryl Sulfate Poloxamer 407 Sodium Phosphate, Tribasic, Dodecahydrate Sodium Hydroxide Saccharin Sodium Carboxymethylcellulose Sodium, Unspecified Xanthan Gum Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-25

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 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, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Poloxamer 407, Trisodium Phosphate, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Titanium Dioxide, Blue 1.

Principal Display Panel 170 G Tube Carton

Colgate®

Anticavity Toothpaste for Sensitive Teeth

MAXIMUM STRENGTH*

Sensitive

WHITENING

Recyclable

Tube

RELIEVES & WHITENS

  • CLINICALLY PROVEN SENSITIVITY RELIEF
  • SUPERIOR STAIN REMOVAL

NET WT 6.0 OZ (170 g)

FRESH MINT

gel


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, Glycerin, Hydrated Silica, Sorbitol, PEG-12, PVM/MA Copolymer, Sodium Lauryl Sulfate, Flavor, Poloxamer 407, Trisodium Phosphate, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Titanium Dioxide, Blue 1.

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

Colgate®

Anticavity Toothpaste for Sensitive Teeth

MAXIMUM STRENGTH*

Sensitive

WHITENING

Recyclable

Tube

RELIEVES & WHITENS

  • CLINICALLY PROVEN SENSITIVITY RELIEF
  • SUPERIOR STAIN REMOVAL

NET WT 6.0 OZ (170 g)

FRESH MINT

gel


Advanced Ingredient Data


Raw Label Data

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