Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID cf6019ae-3b87-4f36-a5a0-05a2a45ed799
Route
ORAL
Published
Effective Date 2013-05-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Water Sorbitol Alcohol Poloxamer 407 Sodium Lauryl Sulfate Eucalyptol Methyl Salicylate Thymol Phosphoric Acid Sucralose Menthol Sodium Phosphate, Dibasic, Anhydrous Fd&c Red No. 40 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-05-09
Description

SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)

Purpose

ANTICAVITY

Medication Information

Purpose

ANTICAVITY

Description

SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)

Uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Warnings

KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).

Directions

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH A TOOTHPASTE. VIGOROUSLY SWISH 10 ML 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. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 12 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

Label Copy

Active Ingredient

SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)

Other Information

STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F). COLD WEATHER MAY CLOUD THIS PRODUCT.

Inactive Ingredients:

WATER (AQUA), SORBITOL, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (CI 42090). 

Questions Or Comments?

1-800-842-7886

Keep Out of Reach of Children

IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).

Structured Label Content

Uses (USES)

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Purpose (PURPOSE)

ANTICAVITY

Warnings (WARNINGS)

KEEP OUT OF REACH OF CHILDREN. IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).

Directions (DIRECTIONS)

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH A TOOTHPASTE. VIGOROUSLY SWISH 10 ML 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. SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION. CHILDREN UNDER 12 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SODIUM FLUORIDE 0.02% (0.01% W/V FLUORIDE ION)

Other Information (OTHER INFORMATION)

STORE AT CONTROLLED ROOM TEMPERATURE 20-25C (68-77F). COLD WEATHER MAY CLOUD THIS PRODUCT.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), SORBITOL, ALCOHOL (21.6%), POLOXAMER 407, SODIUM LAURYL SULFATE, EUCALYPTOL, FLAVOR, METHYL SALICYLATE, THYMOL, PHOSPHORIC ACID, SUCRALOSE, MENTHOL, DISODIUM PHOSPHATE, RED 40 (CI 16035), BLUE 1 (CI 42090). 

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-842-7886

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IF MORE THAN USED FOR RINSING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY (1-800-222-1222).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.897202 · Updated: 2026-03-14T22:53:29.712463