FDA.reportPublic FDA data

CLOSEUP TRAVEL

Manufacturer
GURUNANDA, LLC
Effective date
2022-08-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:25

Label at a glance#

ProductCLOSEUP TRAVEL
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Do not swallow. Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Children under 6 Years of Age: Use only a pea-sized amount and supervise children's brushing and rinsing to minimize swallowing. Children under 2 years of age: Ask a dentist or physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.21%

PURPOSE

OTC - PURPOSE SECTION

Anticavity

USE

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

WARNING

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Do not swallow.

  • Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • Children under 6 Years of Age: Use only a pea-sized amount and supervise children's brushing and rinsing to minimize swallowing.
  • Children under 2 years of age: Ask a dentist or physician

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sorbitor, Water, Silica, Sodium Lauryl Suphate, PEG-32, Titanium Dioxide, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Zinc Sulfate, Sodium Hydroxide, D&C Red 33, FD&C Red 40, Synthetic Fluorphlogopite, Melaleuca Alternifolia (Tea Tree Extract), Eucalyptus Globulus (Eucalyptus Extract), Eugenol

OTC - QUESTIONS SECTION

1-866-421-0309

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL FRONTPRINCIPAL DISPLAY PANEL FRONTPRINCIPAL DISPLAY PANEL BACKPRINCIPAL DISPLAY PANEL BACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099038sodium fluoride 0.21 % ToothpastePSN2
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD2
1099038sodium fluoride 0.21 % ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70708-182-012023-07-28C16284748780-10191ceaa-67aa-198a-e063-dbdaa90aec3eCLOSEUP TOOTHPASTE 79 GM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70708-182-01CLOSEUP TRAVEL1 in 1 POUCHPASTE, DENTIFRICE12
70708-182-80CLOSEUP TRAVEL80 g in 1 TUBEPASTE, DENTIFRICE802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70708-182CLOSEUP TRAVEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [GURUNANDA, LLC]2Legacy NDC, 2 package rows20220816_d46461c0-e36e-1303-e053-2995a90a4967.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70708-18270708-182-80, 70708-182-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS GLOBULUS WHOLESI1P2XF3M3IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
D&C RED NO. 339DBA0SBB0LIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
EUGENOL3T8H1794QWIACT
MELALEUCA ALTERNIFOLIA WHOLE976KV4FXYFIACT
SODIUM SILICATEIJF18F77L3IACT
ZINC SULFATE89DS0H96TBIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
ALPHA CELLULOSEI355QGZ19AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
PEG-32 LAURATEF8XJF81O0FIACT

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
e5eb32b8-1e62-56cc-e053-2a95a90a6134d46461c0-e36e-1303-e053-2995a90a49672022-08-10WarningsExact identifier
spl id: e5eb32b8-1e62-56cc-e053-2a95a90a6134
spl set id: d46461c0-e36e-1303-e053-2995a90a4967

Reported adverse events (FAERS/openFDA)#

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