SPL v1
SPL
SPL Set ID 9a456198-f0d6-4375-a545-9d07fd3eeca6
Route
ORAL
Published
Effective Date 2016-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0225 g)
Inactive Ingredients
Water Glycerin Xylitol Acesulfame Sodium Benzoate Rose Bengal At Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-11-28
Description

Active Ingredient Sodium Fluoride 0.05%

Medication Information

Warnings and Precautions

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

Indications and Usage

Uses:

Helps protect against cavities

Dosage and Administration

Directions:

  • Adults and children 6 years and older:
  • Use daily after your normal brush
  • Shake well before each use
  • Rinse or gargle for 30 seconds with 15 mL (3 teaspoonful) and then spit out
  • Supervise children's brushing untill good habits are established.
  • Do not Swallow the rinse

Description

Active Ingredient Sodium Fluoride 0.05%

Section 44425-7

Other Information

Store in cool and dry place away from direct sun light

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive Ingredients:

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

Section 51945-4

Section 55105-1

Purpose:

Anticavity

Section 55106-9

Active Ingredient

Sodium Fluoride 0.05%

Structured Label Content

Indications and Usage (34067-9)

Uses:

Helps protect against cavities

Dosage and Administration (34068-7)

Directions:

  • Adults and children 6 years and older:
  • Use daily after your normal brush
  • Shake well before each use
  • Rinse or gargle for 30 seconds with 15 mL (3 teaspoonful) and then spit out
  • Supervise children's brushing untill good habits are established.
  • Do not Swallow the rinse

Warnings and Precautions (34071-1)

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

Section 44425-7 (44425-7)

Other Information

Store in cool and dry place away from direct sun light

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive Ingredients:

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Xylitor, Flavor, Acesulfame, Sodium Benzoate, Saccharin Sodium, Rose Red 1

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Anticavity

Section 55106-9 (55106-9)

Active Ingredient

Sodium Fluoride 0.05%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:13.551112 · Updated: 2026-03-14T22:54:33.877898