CLOSE UP TRAVEL- sodium fluoride paste, dentifrice

CLOSE UP TRAVEL by

Drug Labeling and Warnings

CLOSE UP TRAVEL by is a Otc medication manufactured, distributed, or labeled by JHS SVENDGAARD LABORATORIES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Fluoride 0.21%

PURPOSE

Purpose:

Anticavity

INDICATIONS & USAGE

Uses:

Aids in the prevention of dental cavities

WARNINGS

Warnings:

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOSE UP TRAVEL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72025-004
Route of Administration	ORAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72025-004-01	79 g in 1 TUBE; Type 0: Not a Combination Product	12/27/2021
2	NDC: 72025-004-02	24 g in 1 TUBE; Type 0: Not a Combination Product	12/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/27/2021

Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)

Establishment
Name	Address	ID/FEI	Business Operations
JHS SVENDGAARD LABORATORIES LIMITED		675939900	manufacture(72025-004)