drug facts

drug facts
SPL v1
SPL
SPL Set ID c9375caf-f75f-4c3d-b2cf-55e4bb6bd8fc
Route
oral
Published
Effective Date 2013-05-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.5 mg)
Inactive Ingredients
water sorbitol propylene glycol polysorbate 20 sodium phosphate poloxamer 407 sodium benzoate edetate calcium disodium anhydrous potassium sorbate sodium phosphate, dibasic, anhydrous saccharin sodium cetylpyridinium chloride menthol methyl salicylate fd&c green no. 3 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2013-05-09
Purpose

ANTICAVITY

Description

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

Medication Information

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).

Uses

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

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 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 6 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

Other Information

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

Description

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

Label Copy

Active Ingredient

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

Inactive Ingredients:

WATER (AQUA), SORBITOL, PROPYLENE GLYCOL, POLYSORBATE 20, FLAVOR, SODIUM PHOSPHATE, POLOXAMER 407, SODIUM BENZOATE, CALCIUM DISODIUM EDTA, POTASSIUM SORBATE, DISODIUM PHOSPHATE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, MENTHOL, METHYL SALICYLATE, GREEN 3 (CI 42053), YELLOW 5 (CI 19140).

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

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).

Uses (USES)

AIDS IN THE PREVENTION OF DENTAL CAVITIES.

Purpose (PURPOSE)

ANTICAVITY

Directions (DIRECTIONS)

ADULTS AND CHILDREN 6 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 6 YEARS OF AGE: CONSULT A DENTIST OR DOCTOR.

Other Information (OTHER INFORMATION)

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)

Inactive Ingredients: (INACTIVE INGREDIENTS:)

WATER (AQUA), SORBITOL, PROPYLENE GLYCOL, POLYSORBATE 20, FLAVOR, SODIUM PHOSPHATE, POLOXAMER 407, SODIUM BENZOATE, CALCIUM DISODIUM EDTA, POTASSIUM SORBATE, DISODIUM PHOSPHATE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, MENTHOL, METHYL SALICYLATE, GREEN 3 (CI 42053), YELLOW 5 (CI 19140).

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: 2026-02-15T11:55:37.894864 · Updated: 2026-03-14T22:53:29.712463