RxNorm Names

Review RxNorm Normal Forms

DOLLAR GENERAL RADIANT WHITE (fluoride) paste, dentifrice
[Dollar General]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=dab125e4-6aa1-492f-8cd9-81ba2958d4e0

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Active ingredients / Purpose

Sodium fluoride 0.243% ............Anticavity

Uses

aids in the prevention of dental cavities

Children under 2 years of age, consult a dentist or doctor

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

Directions

Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to avoid swallowing). Supervise children as necessary until capable of using without supervision.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, xanthan gum, carbomer, sodium saccharin, sodium hydroxide, mica, titanium dioxide, blue 1 lake, polyethylene

mm1.jpg

Carton label

mm2.jpg

Tube Label

DOLLAR GENERAL RADIANT WHITE
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55910-198
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	0.243 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
SACCHARIN SODIUM
SORBITOL
TITANIUM DIOXIDE
SODIUM HYDROXIDE
XANTHAN GUM
HYDRATED SILICA
SODIUM ACID PYROPHOSPHATE
CARBOXYMETHYLCELLULOSE SODIUM
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
SODIUM LAURYL SULFATE
MICA

Product Characteristics
Color	blue (light blue with sparkles)	Score
Shape		Size
Flavor	MINT (mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:55910-198-89	1 in 1 CARTON
1	NDC:55910-198-82	164 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/20/2011

Labeler - Dollar General (068331990)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(55910-198), pack(55910-198)

Revised: 01/2013

Document Id: 31481304-8cdb-4cc5-a494-7db43b84f18b

Set id: dab125e4-6aa1-492f-8cd9-81ba2958d4e0

Version: 1

Effective Time: 20130123

Dollar General

Daily Med

Current Medication Information

Options

Additional Resources