Label: REGULAR- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0012-4 - Packager: Kareway Product, 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 February 2, 2012
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- Active ingredient
- Purpose
- Usage
- Warnings
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Directions
Adults and children 2 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 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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
REGULAR
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0012 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) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) METHYLPARABEN (UNII: A2I8C7HI9T) AMINOCAPROIC ACID (UNII: U6F3787206) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) MENTHOL (UNII: L7T10EIP3A) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0012-4 1 in 1 BOX 1 181 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 08/15/2011 Labeler - Kareway Product, Inc. (121840057)