CLOSEUP TRAVEL- sodium fluoride paste, dentifrice

CLOSEUP TRAVEL by

Drug Labeling and Warnings

CLOSEUP TRAVEL by is a Otc medication manufactured, distributed, or labeled by GURUNANDA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Sodium Fluoride 0.21%

PURPOSE

Anticavity

USE

Aids in the prevention of dental cavities

WARNING

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

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

DIRECTIONS

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

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

QUESTIONS

1-866-421-0309

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOSEUP TRAVEL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70708-182
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EUGENOL (UNII: 3T8H1794QW)
MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)
SODIUM SILICATE (UNII: IJF18F77L3)
ZINC SULFATE (UNII: 89DS0H96TB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALPHA CELLULOSE (UNII: I355QGZ19A)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PEG-32 LAURATE (UNII: F8XJF81O0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70708-182-01	1 in 1 POUCH	08/01/2022
1	NDC: 70708-182-80	80 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2022

Labeler - GURUNANDA, LLC (079671169)