Label: CHARM TEX- sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 40057-1001-1, 40057-1001-2, 40057-1001-3, 40057-1001-4, view more40057-1001-5, 40057-1001-6 - Packager: Charm Tex, Inc.
- 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 29, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
- Inactive ingredient
- Directions
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 42.5 Grams Tube Label
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INGREDIENTS AND APPEARANCE
CHARM TEX
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40057-1001 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 Sorbitol (UNII: 506T60A25R) 62 g in 100 g Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Lauryl Sulfate (UNII: 368GB5141J) Carboxymethylcellulose Sodium (UNII: K679OBS311) Saccharin Sodium Dihydrate (UNII: SB8ZUX40TY) Methylparaben Sodium (UNII: CR6K9C2NHK) Propylparaben Sodium (UNII: 625NNB0G9N) Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40057-1001-1 141 g in 1 TUBE 2 NDC:40057-1001-2 85 g in 1 TUBE 3 NDC:40057-1001-3 42.5 g in 1 TUBE 4 NDC:40057-1001-4 24 g in 1 TUBE 5 NDC:40057-1001-5 17 g in 1 TUBE 6 NDC:40057-1001-6 4.24 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 06/01/2011 Labeler - Charm Tex, Inc. (058347543)