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 Green No. 3

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2015-08-01 Until 2026-03-31

Medication Information

Purpose

Anticavity

Description

Drug Facts

Uses

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, cetylpyridinium chloride, disodium phosphate, potassium sorbate, sucralose, FD&C green no. 3

Principal Display Panel 1 L Bottle Label

NEW

ALCOHOL FREE

Colgate ^®

Anticavity Fluoride Mouthwash

ENAMEL

HEALTH _™

STRENGTHENS ENAMEL EVEN

WHERE BRUSHING MAY MISS

WITH FLUORIDE

✓
HELPS REPLENISH NATURAL CALCIUM

BACK INTO ENAMEL
✓
REVERSES ENAMEL SOFTENING TO HELP

PREVENT CAVITIES
✓
FRESHENS BREATH

SPARKLING FRESH MINT

33.8 FL OZ

(1.05 QT)

1 L

IMPORTANT:

Read directions

for proper use

P9903598

Structured Label Content

Uses

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, cetylpyridinium chloride, disodium phosphate, potassium sorbate, sucralose, FD&C green no. 3

Principal Display Panel 1 L Bottle Label (PRINCIPAL DISPLAY PANEL - 1 L Bottle Label)

NEW

ALCOHOL FREE

Colgate ^®

Anticavity Fluoride Mouthwash

ENAMEL

HEALTH _™

STRENGTHENS ENAMEL EVEN

WHERE BRUSHING MAY MISS

WITH FLUORIDE

✓
HELPS REPLENISH NATURAL CALCIUM

BACK INTO ENAMEL
✓
REVERSES ENAMEL SOFTENING TO HELP

PREVENT CAVITIES
✓
FRESHENS BREATH

SPARKLING FRESH MINT

33.8 FL OZ

(1.05 QT)

1 L

IMPORTANT:

Read directions

for proper use

P9903598

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": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "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": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "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": "FD&C GREEN NO. 3", "unii": "3P3ONR6O1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "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, cetylpyridinium chloride, disodium phosphate, potassium sorbate, sucralose, FD&C green no. 3", "PRINCIPAL DISPLAY PANEL - 1 L Bottle Label": "NEW ALCOHOL FREE Colgate ® Anticavity Fluoride Mouthwash ENAMEL HEALTH ™ STRENGTHENS ENAMEL EVEN WHERE BRUSHING MAY MISS WITH FLUORIDE ✓ HELPS REPLENISH NATURAL CALCIUM BACK INTO ENAMEL ✓ REVERSES ENAMEL SOFTENING TO HELP PREVENT CAVITIES ✓ FRESHENS BREATH SPARKLING FRESH MINT 33.8 FL OZ (1.05 QT) 1 L IMPORTANT: Read directions for proper use P9903598"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information