Label: SAFETYMAXX MINT FLAVOR- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 60371-339-06, 60371-339-15, 60371-339-27, 60371-339-46, view more60371-339-85 - Packager: FSi, 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 November 15, 2011
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use:
- Warnings
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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.
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
- Product Tube Label
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INGREDIENTS AND APPEARANCE
SAFETYMAXX MINT FLAVOR
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60371-339 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) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM SILICATE (UNII: IJF18F77L3) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY) METHYLPARABEN (UNII: A2I8C7HI9T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60371-339-06 17 g in 1 TUBE 2 NDC:60371-339-85 24 g in 1 TUBE 3 NDC:60371-339-15 43 g in 1 TUBE 4 NDC:60371-339-27 78 g in 1 TUBE 5 NDC:60371-339-46 130 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/15/2011 Labeler - FSi, Inc. (609296694)