Colgate®

Colgate®
SPL v8
SPL
SPL Set ID 2b4b6f9a-0e31-4891-8721-d1b9a58cca96
Route
DENTAL
Published
Effective Date 2019-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2 mg)
Inactive Ingredients
Water Sorbitol Sodium Phosphate Poloxamer 338 Polysorbate 20 Propylene Glycol Potassium Sorbate Phosphoric Acid Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-01-12
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, poloxamer 338, polysorbate 20, propylene glycol, flavor, potassium sorbate, phosphoric acid, FD&C blue no. 1

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate®

Anticavity Fluoride Rinse

Ortho

Defense®

Phos • Flur®

Sodium Fluoride Acidulated

Phosphate Solution

IDEAL PROTECTION

WHILE WEARING BRACES

  • ✓
    ORTHODONTIST RECOMMENDED
  • ✓
    HELPS STRENGTHEN ENAMEL
  • ✓
    HELPS PREVENT CAVITIES

16.9 FL OZ

(1.05 PT)

500 mL

MINT

ADA

Accepted

American

Dental

Association ®

IMPORTANT: Read

directions for proper use

P9933378

Protection between Brushings

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, poloxamer 338, polysorbate 20, propylene glycol, flavor, potassium sorbate, phosphoric acid, FD&C blue no. 1

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

ALCOHOL FREE

Colgate®

Anticavity Fluoride Rinse

Ortho

Defense®

Phos • Flur®

Sodium Fluoride Acidulated

Phosphate Solution

IDEAL PROTECTION

WHILE WEARING BRACES

  • ✓
    ORTHODONTIST RECOMMENDED
  • ✓
    HELPS STRENGTHEN ENAMEL
  • ✓
    HELPS PREVENT CAVITIES

16.9 FL OZ

(1.05 PT)

500 mL

MINT

ADA

Accepted

American

Dental

Association ®

IMPORTANT: Read

directions for proper use

P9933378

Protection between Brushings

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.405305 · Updated: 2026-03-14T23:02:23.126471