Label: AMERFRESH- sodium monofluorophosphate powder, dentifrice
- NDC Code(s): 51460-1113-1, 51460-1113-2
- Packager: Amercare Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)Close
aids in the prevention of dental cavitiesClose
Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.
- Directions For Use
- wet toothbrush and dip into powder until brush is fully covered
- brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
- 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
calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.Close
- SPL UNCLASSIFIED SECTION
Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226.Close
- PRINCIPAL DISPLAY PANEL - 57 g Packet Label
NET WT. 2 oz (57g)
- INGREDIENTS AND APPEARANCE
sodium monofluorophosphate powder, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51460-1113 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.4332 g in 57 g Inactive Ingredients Ingredient Name Strength calcium carbonate (UNII: H0G9379FGK) carboxymethylcellulose sodium (UNII: K679OBS311) saccharin sodium (UNII: SB8ZUX40TY) sodium lauryl sulfate (UNII: 368GB5141J) hydrated silica (UNII: Y6O7T4G8P9) methylparaben sodium (UNII: CR6K9C2NHK) propylparaben sodium (UNII: 625NNB0G9N) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51460-1113-1 57 g in 1 PACKET 2 NDC:51460-1113-2 446 g in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 12/20/2011 Labeler - Amercare Products, Inc. (879289254)