Label: AMERFRESH FLUORIDE- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 51460-3001-1 - 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 September 14, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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Directions
- Adults and children 2 yrs. and older: Brush teeth throughtly after meals or at least twice a day or as directed by a dentist.
- Do not swallow
- To minimize swallowing, use a pea-sized amount in children under 6 years old.
- Supervise children's brushing until good habits are established.
- Children under 2 yrs.: ask a dentist before use.
- Inactive Ingredients
- AmerFresh Fluoride Toothpaste
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INGREDIENTS AND APPEARANCE
AMERFRESH FLUORIDE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-3001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HYDRATED SILICA (UNII: Y6O7T4G8P9) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51460-3001-1 7.1 g in 1 PACKAGE; Type 0: Not a Combination Product 09/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/12/2016 Labeler - Amercare Products, Inc. (879289254) Registrant - Amercare Products, Inc. (879289254)