Rexall 004.002/004ae

Rexall 004.002/004ae
SPL v27
SPL
SPL Set ID f8036e2e-7541-4922-92b9-0d8319f7b64c
Route
ORAL
Published
Effective Date 2025-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Benzyl Alcohol Edetate Calcium Disodium Anhydrous Cetylpyridinium Chloride Edetate Disodium Sodium Phosphate, Dibasic, Anhydrous Poloxamer 407 Polysorbate 80 Propylene Glycol D&c Red No. 33 Sodium Benzoate Sodium Phosphate Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-24 Until 2024-09-16
Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Use

aids in the prevention of dental cavities

Warnings

for this product

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 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

Adverse Reaction

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY Old East Main CO,

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information
  • store at room temperture
Inactive Ingredients

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel

Since 1903

Rexall™

kids

Anticavity

Fluoride Rinse

Anticavitvy Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • Alcohol free

IMPORTANT: read directions for proper use.

ADA Accepted

America Dental Association

Helps Prevent cavities

Bubblegum Flavor

500 mL (1.05 PT) 16.9 FL OZ

Tamper Evident Statement

Sealed with printed neckband for your protection

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center immediately.

Structured Label Content

Use

aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

for this product

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 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

Adverse Reaction

Visit us at: Rexall.com or call 1-866-4-REXALL

DISTRIBUTED BY Old East Main CO,

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

Active Ingredient (Active ingredient)

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Other Information (Other information)
  • store at room temperture
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Principal Display Panel (Principal display panel)

Since 1903

Rexall™

kids

Anticavity

Fluoride Rinse

Anticavitvy Fluoride Rinse

  • Helps prevent cavities
  • Helps strengthen teeth
  • Alcohol free

IMPORTANT: read directions for proper use.

ADA Accepted

America Dental Association

Helps Prevent cavities

Bubblegum Flavor

500 mL (1.05 PT) 16.9 FL OZ

Tamper Evident Statement

Sealed with printed neckband for your protection

Keep Out of Reach of Children. (Keep out of reach of children.)

If more than used for rinsing is accidentally swallowed, see professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:51.442941 · Updated: 2026-03-14T23:14:02.652954