Label: ANTI CAVITY FLUORIDE- sodium monofluorophosphate paste
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Contains inactivated NDC Code(s)
NDC Code(s): 52000-036-46 - Packager: Universal Distribution Center LLC
- 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 June 21, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- adults and children of 6 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
- do not swallow.
- to minimize swallowing, use pea-sized amount in children under 6 years old.
- supervise child's brushing until good habits are established.
- children under 2 years: ask a dentist before use.
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI CAVITY FLUORIDE
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-036 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 7.6 mg in 1 g Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE (UNII: H0G9379FGK) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM SILICATE (UNII: IJF18F77L3) SORBITOL (UNII: 506T60A25R) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-036-46 1 in 1 BOX 06/21/2017 1 181 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 06/21/2017 Labeler - Universal Distribution Center LLC (019180459) Registrant - Universal Distribution Center LLC (019180459) Establishment Name Address ID/FEI Business Operations Yangzhou Holyshine Industrial Co. Ltd 421141948 manufacture(52000-036)