Label: CLOSE UP TRAVEL- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72025-004-01, 72025-004-02 - Packager: JHS SVENDGAARD LABORATORIES LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 10, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
CLOSE UP TRAVEL
sodium fluoride paste, dentifriceProduct 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)
