SPL v1
SPL
SPL Set ID 2a6bf243-b167-484d-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2016-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (243 mg)
Inactive Ingredients
Sorbitol Water Sodium Hydroxide Saccharin Sodium Dihydrate Glycerin Carboxymethylcellulose Sodium Polysorbate 80 Xanthan Gum Titanium Dioxide Fd&c Yellow No. 5 Sodium Benzoate Cetylpyridinium Chloride Benzoic Acid Fd&c Blue No. 1 Hydrated Silica Sodium Acid Pyrophosphate Sodium Lauryl Sulfate Alcohol

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-28
Description

ACTIVE INGREDIENT Sodium Fluoride

Medication Information

Warnings and Precautions

WARNINGS

kEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE.IF MORE THAT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL VENTER RIGHT AWAY.

Indications and Usage

DIRECTIONS

  • Adults and children 2 yrs. & older; brush teeth thoroughly after meals or at least twice a day or use as directed a dentist
  • do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's brushing until good habits are established

  • children under 2 yrs, ask a dentist
Dosage and Administration

DIRECTION

Adults and childreen 2 yrs and older ; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist

Description

ACTIVE INGREDIENT Sodium Fluoride

Section 50565-1

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS

Section 51727-6

sorbitol,water,hydrated silica,disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol, xanthan gum, sodium saccharin , glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cethylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Section 51945-4

Section 53413-1

QUESTIONS?

1-800-492-7378

Section 55105-1

PURPOSE

Anticavity toothpaste

Section 55106-9

ACTIVE INGREDIENT

Sodium Fluoride

Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS

  • Adults and children 2 yrs. & older; brush teeth thoroughly after meals or at least twice a day or use as directed a dentist
  • do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children's brushing until good habits are established

  • children under 2 yrs, ask a dentist
Dosage and Administration (34068-7)

DIRECTION

Adults and childreen 2 yrs and older ; brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist

Warnings and Precautions (34071-1)

WARNINGS

kEEP OUT OF REACH OF CHILDREN UNDER 6 YRS OF AGE.IF MORE THAT USED FOR BRUSHING IS ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL VENTER RIGHT AWAY.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS

Section 51727-6 (51727-6)

sorbitol,water,hydrated silica,disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, alcohol, xanthan gum, sodium saccharin , glycerin, carbomer, cellulose gum, polysorbate 80, sodium benzoate, cethylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS?

1-800-492-7378

Section 55105-1 (55105-1)

PURPOSE

Anticavity toothpaste

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

Sodium Fluoride

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:03.690513 · Updated: 2026-03-14T22:54:14.381059