Label: AMAR- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 41499-107-01, 41499-107-02 - Packager: Amar Remedies Limited - Mumbai
- 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 December 22, 2009
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
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Directions
Adults and children 6 years of age and older Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Children 2 to 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 physician. - Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 181 g Carton
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INGREDIENTS AND APPEARANCE
AMAR ADVANCED WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41499-107 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 Water (UNII: 059QF0KO0R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41499-107-01 181 g in 1 TUBE 2 NDC:41499-107-02 181 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 12/01/2009 Labeler - Amar Remedies Limited - Mumbai (677141751)