Label: VITA FRESH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 76173-1003-1, 76173-1003-2 - Packager: Cellinbio Co Ltd
- 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 July 27, 2011
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Drug Facts
Active ingredient
Sodium monofluorophosphate 0.75%
Keep out of Reach of Children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.
Indication & Usage
Directions
Do not swallow
Supervise children as necessary until capable of using without supervision
Adults, Children 6 years of age, 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: Use only a pea sized amount and supervise child's brushing and rinsing(to minimize swallowing).
Children under 2 years: ask a dentist or doctor.
Warnings
Warnings
Stop use and ask a dentist if problems persists or worsens. Sensitive teeth may indicate a serious problem that may require prompt care by a dentist.
Inactive Ingredient
Silica, Tocopheryl Acetate, Aluminum chlorohydrate, Sorbitol, Polyethylene Glycol 1500, Hydrated silica, Cellulose Gum, Xylitol, Sodium Saccharin, Sodium Lauryl Sulfate, Camellia Sinensis Leaf Extract, Menthol, Mentha Virdis(Spearmint) Leaf Oil, Beta-carotene, CI 19140, CI 77480, Water
- Vita Fresh Toothpaste
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INGREDIENTS AND APPEARANCE
VITA FRESH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76173-1003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 1.125 g in 150 g Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALUMINUM CHLOROHYDRATE (UNII: HPN8MZW13M) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) HYDRATED SILICA (UNII: Y6O7T4G8P9) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LEVOMENTHOL (UNII: BZ1R15MTK7) SPEARMINT OIL (UNII: C3M81465G5) BETA CAROTENE (UNII: 01YAE03M7J) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) GOLD (UNII: 79Y1949PYO) WATER (UNII: 059QF0KO0R) Product Characteristics Color yellow (green and black) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76173-1003-2 1 in 1 BOX 1 NDC:76173-1003-1 150 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/27/2011 Labeler - Cellinbio Co Ltd (557803737) Registrant - Cellinbio Co Ltd (557803737) Establishment Name Address ID/FEI Business Operations Cellinbio Co Ltd 557803737 relabel Establishment Name Address ID/FEI Business Operations KOLMAR KOREA CO LTD 687846360 manufacture
