CLOSE UP TRAVEL- sodium fluoride paste, dentifrice 
JHS SVENDGAARD LABORATORIES LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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72025-004

Active Ingredient

Sodium Fluoride 0.21%

Purpose:

Anticavity

Uses:

Aids in the prevention of dental cavities

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 under 6 years of age

Directions:

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

image description

CLOSE UP TRAVEL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72025-004
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72025-004-0179 g in 1 TUBE; Type 0: Not a Combination Product12/27/2021
2NDC:72025-004-0224 g in 1 TUBE; Type 0: Not a Combination Product12/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/27/2021
Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)
Establishment
NameAddressID/FEIBusiness Operations
JHS SVENDGAARD LABORATORIES LIMITED675939900manufacture(72025-004)

Revised: 8/2022
Document Id: e5ec21b7-c798-b8af-e053-2995a90a870e
Set id: c9a4c874-a35e-4221-a627-6421d5a70f26
Version: 2
Effective Time: 20220810
 
JHS SVENDGAARD LABORATORIES LIMITED