Label: AMERFRESH- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51460-1112-0, 51460-1112-1, 51460-1112-2, 51460-1112-3, view more51460-1112-4, 51460-1112-5, 51460-1112-6, 51460-1112-7, 51460-1112-8, 51460-1112-9, 51460-1114-0 - 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 January 15, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warning
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Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
- 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 doctor.
- Children under 6 years of age: Do not use unless directed by a doctor or dentist
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1112
- PRINCIPAL DISPLAY PANEL - 85 g Tube Label - NDC 51460-1114
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INGREDIENTS AND APPEARANCE
AMERFRESH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-1112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1 mg in 1 g Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Sodium Lauryl Sulfate (UNII: 368GB5141J) Carboxymethylcellulose Sodium (UNII: K679OBS311) Saccharin Sodium (UNII: SB8ZUX40TY) Methylparaben Sodium (UNII: CR6K9C2NHK) Propylparaben Sodium (UNII: 625NNB0G9N) 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:51460-1112-1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51460-1112-2 7.1 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:51460-1112-3 1 in 1 BOX 3 85 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51460-1112-4 17 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:51460-1112-5 24 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:51460-1112-6 43 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:51460-1112-7 1 in 1 BOX 7 43 g in 1 TUBE; Type 0: Not a Combination Product 8 NDC:51460-1112-8 130 g in 1 TUBE; Type 0: Not a Combination Product 9 NDC:51460-1112-9 181 g in 1 TUBE; Type 0: Not a Combination Product 10 NDC:51460-1112-0 142 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/14/2012 AMERFRESH
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-1114 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1 mg in 1 g Inactive Ingredients Ingredient Name Strength Calcium Carbonate (UNII: H0G9379FGK) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Hydrated Silica (UNII: Y6O7T4G8P9) Sodium Lauryl Sulfate (UNII: 368GB5141J) Carboxymethylcellulose Sodium (UNII: K679OBS311) Saccharin Sodium (UNII: SB8ZUX40TY) Methylparaben Sodium (UNII: CR6K9C2NHK) Propylparaben Sodium (UNII: 625NNB0G9N) 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:51460-1114-0 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 11/14/2012 Labeler - Amercare Products, Inc. (879289254)