Colgate ®

Colgate ®
SPL v2
SPL
SPL Set ID 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd
Route
DENTAL
Published
Effective Date 2017-10-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2 mg)
Inactive Ingredients
Water Sorbitol Sodium Phosphate, Monobasic, Monohydrate Potassium Sorbate Phosphoric Acid Polysorbate 20 Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-08-01
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 once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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
  • ask a dentist or physician
Questions?

1-800-468-6502

Active Ingredient

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Other Information

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

Inactive Ingredients

water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE*

Colgate ®

Phos•Flur ®

Ortho Defense ®

Anticavity Fluoride Rinse

IDEAL PROTECTION



WHILE WEARING BRACES

  • ORTHODONTIST RECOMMENDED
  • HELPS STRENGTHEN ENAMEL
  • HELPS PREVENT CAVITIES

GUSHING GRAPE

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

ADA



Accepted



American



Dental



Association ®

P9895933

Phos Flur Artwork

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 once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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
  • ask a dentist or physician
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Other Information

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

Inactive Ingredients (Inactive ingredients)

water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

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

ALCOHOL FREE*

Colgate ®

Phos•Flur ®

Ortho Defense ®

Anticavity Fluoride Rinse

IDEAL PROTECTION



WHILE WEARING BRACES

  • ORTHODONTIST RECOMMENDED
  • HELPS STRENGTHEN ENAMEL
  • HELPS PREVENT CAVITIES

GUSHING GRAPE

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT: Read directions for proper use

ADA



Accepted



American



Dental



Association ®

P9895933

Phos Flur Artwork

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:58.855760 · Updated: 2026-03-14T22:55:48.069158