colgate®

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.1 mg)

Inactive Ingredients

water glycerin propylene glycol sorbitol poloxamer 407 poloxamer 338 peg-40 castor oil phosphoric acid saccharin sodium sodium phosphate, dibasic, unspecified form potassium sorbate cetylpyridinium chloride sucralose fd&c green no. 3 d&c red no. 33

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2022-01-05

Medication Information

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 supervison

Children under 6 years of age: consult a dentist or doctor

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, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

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

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate^®

Anticavity Fluoride Rinse

Kids

✓
Strengthens

Enamel
✓
Protects from

Cavities
✓
Cleans the

Whole Mouth*

16.9 FL OZ

(1.05 PT) 500 mL

BUBBLE FRUIT^®

IMPORTANT: Read directions for proper use

PS0029450

Structured Label Content

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 supervison

Children under 6 years of age: consult a dentist or doctor

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, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

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

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

ALCOHOL FREE

Colgate^®

Anticavity Fluoride Rinse

Kids

✓
Strengthens

Enamel
✓
Protects from

Cavities
✓
Cleans the

Whole Mouth*

16.9 FL OZ

(1.05 PT) 500 mL

BUBBLE FRUIT^®

IMPORTANT: Read directions for proper use

PS0029450

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 338", "unii": "F75JV2T505", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-40 CASTOR OIL", "unii": "4ERD2076EF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM", "unii": "GR686LBA74", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 supervison 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, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.", "PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label": "ALCOHOL FREE Colgate ® Anticavity Fluoride Rinse Kids ✓ Strengthens Enamel ✓ Protects from Cavities ✓ Cleans the Whole Mouth* 16.9 FL OZ (1.05 PT) 500 mL BUBBLE FRUIT ® IMPORTANT: Read directions for proper use PS0029450"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information