国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION)
CREDENTIS AG
ORAL
OTC DRUG
ANTICAVITY AIDS IN THE PREVENTION OF DENTAL CAVITIES - ANTICAVITY DENTAL RINSE - RESTORES ENAMEL - FOR THE TREATMENT OF WHITE SPOTS
OTC monograph final
CURODONT REPAIR FLUORIDE PLUS- SODIUM FLUORIDE SPONGE CREDENTIS AG _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._ ---------- CURODONT REPAIR FLUORIDE PLUS - DISTRIBUTED BY STRAUMANN ACTIVE INGREDIENTS SODIUM FLUORIDE 0.05% (0.02% W/V FLUORIDE ION) PURPOSE ANTICAVITY USES AIDS IN THE PREVENTION OF DENTAL CAVITIES ANTICAVITY DENTAL RINSE RESTORES ENAMEL FOR THE TREATMENT OF WHITE SPOTS WARNING FOR TOPICAL INTRAORAL USE ONLY. FOR PROFESSIONAL OFFICE USE ONLY. THIS PRODUCT IS NOT INTENDED FOR HOME OR UNSUPERVISED CONSUMER USE. KEEP OUT OF REACH OF CHILDREN. DIRECTIONS Usual dosage is one treatment per tooth. After prophylaxis treatment, remove the pellicle of the concerned tooth by using 2% sodium hypochlorite for 10 seconds. rinse the tooth surface with water. Remove inorganic deposits by pushing together the two cylinders and apply product with sponge on treatment area. After treatment time of five minutes have patient expectorate residues. For maximum benefits for the prevention of caries, instruct patient not to rinse, eat or drink for 30 minutes. For patients with rampant or active caries, repeat treatment once or twice every six months. OTHER INFORMATION DO NOT USE IF SAFETY PACHAGING IS BROKEN OR MISSING. SINGLE USE ONLY. STORE IN A DRY AND COOL PLACE. INACTIVE INGREDIENTS WATER, CHLORHEXIDINE DIGLUCONATE, TROMETHAMINE, TREHALOSE DIHYDRATE, OLIGOPEPTIDE-104, HYDROXYPROPYL METHYLCELLULOSE CURODONT REPAIR FLUORIDE PLUS sodium fluoride sponge PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:72247-10 5 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRE NG TH STRE NG TH SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - 0 .0 5 g CREDENTIS AG SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 0 .0 5 g in 10 0 mL INACTIVE 阅读完整的文件