Label: CURODONT REPAIR FLUORIDE PLUS- sodium fluoride sponge
- NDC Code(s): 72247-108-01, 72247-108-02, 72247-108-03, 72247-108-04
- Packager: CREDENTIS AG
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 23, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
- See package insert for specific instructions for product activation
- From the Curodont Repair Fluoride Plus box, retrieve one UNIT A and peel off the color.
- From the pouch, retrieve one UNIT B. Keep the remaining unused UNIT B in the pouch for future use. Do not replace UNIT B with water, saline, or any other liquid. UNIT A and UNIT B are intended to always be used together.
- Pour the entire contents of UNIT B into the UNIT A receptacle containing the sponge, letting it absorb the liquid for at least 5 minutes to fully activate the proprietary formulation. Meanwhile, proceed with preparing the treatment site. Each set of UNIT A and UNIT B is intended to treat one initial lesion in a single patient.
- Perform oral prophylaxis on the teeth to be treated, including removal of the salivary pellicle using your preferred method (pumice/prophy paste/air polisher/2% sodium hypochlorite). Rinse and dry.
- Etch using 35% phosphoric acid for 20 seconds. For interproximal sites, use unwaxed dental floss to apply the etchant, if needed. Rinse.
- After ensuring that the sponge in UNIT A is fully soaked and soft, isolate the treatment site using basic aids such as cotton rolls, saliva ejector, dry aids, etc. Rubber dam is not necessary.
- Use cotton pliers to firmly grip the saturated sponge in UNIT A from one of its corners.
- Press the sponge on the lesion surface until the formula is deposited and hte sponge starts to appear dry. Use only saturated sponge per lesion. One 'lesion' is defined as one lesion on occlusal/buccal/lingual surfaces or one interproximal site with lesions on one or both adjacent surfaces.
- For interproximal sites, press the saturated sponge starting from lingual embrasure, moving to the buccal and, for any residual formula, the occlusal. Separators or wedges are not needed.
- Wait for 5 minutes before asking the patient to expectorate residues, if any. Dispose the used UNIT A and UNIT B.
- Instruct the patient not to rinse, eat or drink for 30 minutes.
- Other information
- Inactive Ingredients
- Questions? Comments?
- DOSAGE & ADMINISTRATION
- Package Label - PDP - Box x10 - 72247-108-03
- PRINCIPAL DISPLAY PANEL
- Package Label - PDP - Box x20 - 72247-108-04
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INGREDIENTS AND APPEARANCE
CURODONT REPAIR FLUORIDE PLUS
sodium fluoride spongeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72247-108 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.02 g in 100 mL Inactive Ingredients Ingredient Name Strength OLIGOPEPTIDE-104 (UNII: MUM5TLH7X6) TROMETHAMINE (UNII: 023C2WHX2V) HYPROMELLOSES (UNII: 3NXW29V3WO) SODIUM HYDROXIDE (UNII: 55X04QC32I) CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) TREHALOSE DIHYDRATE (UNII: 7YIN7J07X4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72247-108-03 2 in 1 BOX 12/31/2024 1 NDC:72247-108-02 5 in 1 POUCH 1 NDC:72247-108-01 0.25 mL in 1 DOSE PACK; Type 0: Not a Combination Product 2 NDC:72247-108-04 4 in 1 BOX 12/31/2024 2 NDC:72247-108-02 5 in 1 POUCH 2 NDC:72247-108-01 0.25 mL in 1 DOSE PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 12/31/2024 Labeler - CREDENTIS AG (485450345)



