smart way™

smart way™
SPL v1
SPL
SPL Set ID 45cc7a60-b4a7-4263-a114-f0d1f98a87fc
Route
dental
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.13 g)
Inactive Ingredients
sorbitol hydrated silica water polyethylene glycol 1600 sodium lauryl sulfate glycerin carboxymethylcellulose sodium, unspecified titanium dioxide sodium pyrophosphate sodium benzoate benzyl alcohol saccharin sodium sodium phosphate, tribasic, anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-04

Purpose

Anticavity

Description

Sodium Mono-fluorophosphate 0.76 % (0.13 % w/v Fluoride ion)


Medication Information

Warnings

Uses

helps protect against cavities.

Purpose

Anticavity

Directions

adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 

do not swallow.

children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

Sorbitol, Hydrated Silica, Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Description

Sodium Mono-fluorophosphate 0.76 % (0.13 % w/v Fluoride ion)

Section 42229-5

saving in the right direction.

with active fluoride

PROUDLY DISTRIBUTED

BY THE KROGER CO.

CINCINNATI, OHIO 45202

Quality Guarantee If you are not completely satisfied with this product, return it for a refund or replacement.

www.kroger.com

For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

Section 50565-1

Keep out of reach of children under 6 years of age. 

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient

Sodium Mono-fluorophosphate 0.76 %

(0.13 % w/v Fluoride ion)

Questions Or Comments?

Call toll free 1-800-632-6900


Structured Label Content

Warnings

Uses

helps protect against cavities.

Purpose

Anticavity

Directions

adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 

do not swallow.

children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients (Inactive ingredients)

Sorbitol, Hydrated Silica, Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (Cl 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Section 42229-5 (42229-5)

saving in the right direction.

with active fluoride

PROUDLY DISTRIBUTED

BY THE KROGER CO.

CINCINNATI, OHIO 45202

Quality Guarantee If you are not completely satisfied with this product, return it for a refund or replacement.

www.kroger.com

For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. 

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Sodium Mono-fluorophosphate 0.76 %

(0.13 % w/v Fluoride ion)

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-632-6900


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)