Rexall Travel Toothbrush and Tooth-paste

Manufacturer
Old East Main CO. | Ashtel Studios, Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:25:31

Label at a glance#

ProductRexall Travel Toothbrush and Tooth-paste
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Dosage and administration

• Adults and children 2 years of age & older:  brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing • Children under 2 years: ask a dentist or physician.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76%
(0.13% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings:

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the 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 years of age & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing to minimize swallowing
• Children under 2 years: ask a dentist or physician.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-866-4-REXALL

SPL UNCLASSIFIED SECTION

Conforms to airline carry-on regulations

TO ASSEMBLE TOOTHBRUSH:
Insert plug end of toothbrush into handle for use.
Insert brush end of toothbrush into handle for storage.

Visit us at : Rexall.com 

Since 1903 Rexall™ is a Trademark of Rexall Sundown, Inc.

DISTRIBUTED BY OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

MADE IN INDIA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Old East Main -087Old East Main -087

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN3
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY3
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-087-012024-10-15C16284748780-11030e365-6b94-111a-e063-dadaa90a10e2Rexall™ Travel Toothbrush and Toothpaste
55910-087-012024-01-30C16284748780-11030e365-6b94-111a-e063-dadaa90a10e2Rexall™ Travel Toothbrush and Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-087-01Rexall Travel Toothbrush and Tooth-paste1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-087REXALL TRAVEL TOOTHBRUSH AND TOOTH-PASTE (SODIUM MONOFLUOROPHOSPHATE) KIT [OLD EAST MAIN CO.]3Current NDC, Legacy NDC, 1 package rows20241017_1bfba18b-1418-4c39-b666-96fa0674cc70.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-08755910-087-01
55910-090

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rexall Travel Toothbrush and Tooth-pasteSODIUM MONOFLUOROPHOSPHATEOld East Main CO.1bfba18b-1418-4c39-b666-96fa0674cc702024-10-14WarningsExact identifier
ndc (package): 55910-087-01
ndc (product): 55910-087
ndc11 (package): 55910008701
spl id: 6b3f8169-e476-425b-a9c8-f28b1cf6aadd
spl set id: 1bfba18b-1418-4c39-b666-96fa0674cc70

Reported adverse events (FAERS/openFDA)#

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