FDA.reportPublic FDA data

CREST CAVITY PROTECTION COOL MINT

Manufacturer
A-S Medication Solutions
Effective date
2024-06-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:13:33

Label at a glance#

ProductCREST CAVITY PROTECTION COOL MINT
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect teeth and roots against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble, Cincinnati OH 45202

www.crest.com

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-6233

NDC: 50090-6233-0 161 g in a TUBE / 24 in a CASE

Sodium Fluoride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN4
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6233-0CREST CAVITY PROTECTION COOL MINT24 in 1 CASEGEL, DENTIFRICE244
50090-6233-0CREST CAVITY PROTECTION COOL MINT161 g in 1 TUBEGEL, DENTIFRICE1614

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6233CREST CAVITY PROTECTION COOL MINT (SODIUM FLUORIDE) GEL, DENTIFRICE [A-S MEDICATION SOLUTIONS]4Current NDC, 2 package rows20240613_dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-623350090-6233-0
37000-025

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASICA752Q30A6XIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PHOSPHATESE337SVY37IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Cavity Protection Cool Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d7fffb9-47e0-73cd-e054-00144ff88e882026-01-08WarningsExact identifier
ndc (product): 37000-025
CREST CAVITY PROTECTION COOL MINTSODIUM FLUORIDEA-S Medication Solutionsdba7a572-a2f0-4c95-b2a7-cf7301e8ca9d2024-06-12WarningsExact identifier
ndc (package): 50090-6233-0
ndc (product): 50090-6233
ndc11 (package): 50090623300
spl id: 68837a96-c110-476f-9976-3d8d431a130c
spl set id: dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d

Reported adverse events (FAERS/openFDA)#

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