Label: ORABRITE- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 54371-471-01, 54371-471-02, 54371-471-03 - Packager: Oraline, Inc.
- Category: HUMAN OTC DRUG LABEL
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 November 14, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Keep Out Of Reach Of Children
- Use
- Warnings
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Directions
DIRECTIONS:
Adults and children 2 tears of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in god brushing and rinsing habits. (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
- Inactive Ingredients
- Package Label
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INGREDIENTS AND APPEARANCE
ORABRITE
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54371-471 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) METHYLPARABEN SODIUM (UNII: CR6K9C2NHK) PROPYLPARABEN SODIUM (UNII: 625NNB0G9N) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54371-471-01 24 g in 1 TUBE 2 NDC:54371-471-02 43 g in 1 TUBE 3 NDC:54371-471-03 78 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 10/31/2011 Labeler - Oraline, Inc. (179259361) Registrant - Oraline, Inc. (179259361) Establishment Name Address ID/FEI Business Operations Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd. 527127383 manufacture(54371-471)