Supersmile

Manufacturer: Robell Research, Inc.
Effective date: 2020-08-03
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 23:19:23

Label at a glance#

ProductSupersmile

Active ingredientSODIUM MONOFLUOROPHOSPHATE

Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

For the best results: Brush teeth thoroughly after each meal at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. For children under two years of age, consult a dentist or a doctor before use.

Label contents#

Full prescribing information#

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity toothpaste

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings:

WARNINGS SECTION

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

As with all fluoride toothpastes, keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Dicalcium Phosphate Dihydrate, Calcium Carbonate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Flavor, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Sodium Saccharin

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supersmile®

ROSEWATER MINT

professional

whitening

toothpaste

with fluoride.

Net wt. 4.2 oz / 119 g

Rosewater_image.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Supersmile
Sodium Monofluorophosphate
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM PERBORATE TETRAHYDRATE
MAGNESIUM CARBONATE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FLUORIDE ION
WATER
CALCIUM PEROXIDE
SORBITOL
CALCIUM CARBONATE
STARCH, CORN
SODIUM LAURYL SULFOACETATE
SACCHARIN SODIUM
SODIUM BICARBONATE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53567-0748	53567-0748-2, 53567-0748-3, 53567-0748-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
SODIUM PERBORATE TETRAHYDRATE	822HSQ655R	IACT
MAGNESIUM CARBONATE	0E53J927NA	IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	O7TSZ97GEP	IACT
SODIUM MONOFLUOROPHOSPHATE	C810JCZ56Q	ACTIM
WATER	059QF0KO0R	IACT
CALCIUM PEROXIDE	7FRO2ENO91	IACT
SORBITOL	506T60A25R	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
STARCH, CORN	O8232NY3SJ	IACT
SODIUM LAURYL SULFOACETATE	D0Y70F2B9J	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BICARBONATE	8MDF5V39QO	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
abfb8bbf-a5bd-119f-e053-2995a90a0590			5f4bd0ff-4ea2-3756-e053-2991aa0af689	2020-08-03	Warnings	Exact identifier spl id: abfb8bbf-a5bd-119f-e053-2995a90a0590 spl set id: 5f4bd0ff-4ea2-3756-e053-2991aa0af689

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.