Colgate®

Colgate®
SPL v5
SPL
SPL Set ID f0cca38b-c0a3-4788-8cca-727a5684c16b
Route
DENTAL
Published
Effective Date 2020-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Poloxamer 407 Poloxamer 338 Polyoxyl 40 Hydrogenated Castor Oil Phosphoric Acid Saccharin Sodium Cetylpyridinium Chloride Sodium Phosphate, Dibasic, Anhydrous Potassium Sorbate Sucralose Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-03

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age:

consult a dentist or doctor

Questions?

1-800-468-6502

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Cetylpyridinium Chloride, Disodium Phosphate, Potassium Sorbate, Sucralose, Green 3

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate®

Anticavity Fluoride Mouthwash

ENAMEL

STRENGTH®

ANTICAVITY PROTECTION

WITH FLUORIDE FOR STRONGER TEETH

Strengthens Enamel

Helps Prevent Cavities

Helps replenish natural calcium

back into enamel

10X LONGER LASTING COOL**

SPARKLING FRESH MINT

P9932531

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT:

Read directions

for proper use


Structured Label Content

Use

aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age:

consult a dentist or doctor

Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Other Information (Other information)

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Cetylpyridinium Chloride, Disodium Phosphate, Potassium Sorbate, Sucralose, Green 3

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

ALCOHOL FREE

Colgate®

Anticavity Fluoride Mouthwash

ENAMEL

STRENGTH®

ANTICAVITY PROTECTION

WITH FLUORIDE FOR STRONGER TEETH

Strengthens Enamel

Helps Prevent Cavities

Helps replenish natural calcium

back into enamel

10X LONGER LASTING COOL**

SPARKLING FRESH MINT

P9932531

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT:

Read directions

for proper use


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)