Label: AMERFRESH- sodium monofluorophosphate powder
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Contains inactivated NDC Code(s)
NDC Code(s): 51460-0502-1, 51460-0502-2 - Packager: Amercare Products 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 May 12, 2011
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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 - 446 g Carton
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INGREDIENTS AND APPEARANCE
AMERFRESH
sodium monofluorophosphate powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-0502 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) 94.98 g in 100 g Carboxymethylcellulose Sodium (UNII: K679OBS311) Saccharin Sodium (UNII: SB8ZUX40TY) Sodium Lauryl Sulfate (UNII: 368GB5141J) Methylparaben Sodium (UNII: CR6K9C2NHK) Propylparaben Sodium (UNII: 625NNB0G9N) Silicon Dioxide (UNII: ETJ7Z6XBU4) Ponceau 4R (UNII: Z525CBK9PG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51460-0502-1 446 g in 1 POUCH 2 NDC:51460-0502-2 57 g in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 01/01/1996 Labeler - Amercare Products Inc (879289254)