Label: ORAZEN- sodium monofluorophosphate paste
- NDC Code(s): 71927-102-01
- Packager: Orazen Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 13, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions:adults and children 2yrs.and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. To minimize swallowing use a pea sized amount in children under 6. Supervise children's brushing until good habits are established. Children under 2 yrs.:ask a dentist
- INACTIVE INGREDIENT
- QUESTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ORAZEN
sodium monofluorophosphate pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71927-102 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.1 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MICA (UNII: V8A1AW0880) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM PHOSPHIDE (UNII: A360RQX9W2) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71927-102-01 1 in 1 POUCH 04/01/2023 1 28 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 not final part356 04/01/2023 Labeler - Orazen Inc (080916640) Registrant - Orazen Inc (080916640) Establishment Name Address ID/FEI Business Operations YANGZHOU SION COMMODITY CO 546806042 manufacture(71927-102)