Colgate®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.1 mg)

Inactive Ingredients

Water Glycerin Propylene Glycol Sorbitol Potassium Sorbate Cetylpyridinium Chloride Saccharin Sodium Sucralose Poloxamer 407 Poloxamer 338 Sodium Phosphate, Dibasic, Anhydrous Peg-40 Castor Oil Phosphoric Acid Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-08-01

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 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1

Principal Display Panel 500 Ml Bottle Label

NEW

ALCOHOL FREE

Colgate ^®

Kids Anticavity Fluoride Rinse

ILLUMINATION

ENTERTAINMENT

minions_™

16.9 FL OZ

(1.05 PT) 500 mL

P9902670

BELLO™ BUBBLE FRUIT^®

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

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1

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

NEW

ALCOHOL FREE

Colgate ^®

Kids Anticavity Fluoride Rinse

ILLUMINATION

ENTERTAINMENT

minions_™

16.9 FL OZ

(1.05 PT) 500 mL

P9902670

BELLO™ BUBBLE FRUIT^®

IMPORTANT: Read directions for proper use

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "aids in the prevention of dental cavities", "42229-5": "Drug Facts", "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": "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 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, FD&C blue no. 1", "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label": "NEW ALCOHOL FREE Colgate ® Kids Anticavity Fluoride Rinse ILLUMINATION ENTERTAINMENT minions ™ 16.9 FL OZ (1.05 PT) 500 mL P9902670 BELLO™ BUBBLE FRUIT ® IMPORTANT: Read directions for proper use"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information