Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Fluoritab Corporation
ORAL
PRESCRIPTION DRUG
PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL) ACTIONS AND INDICATIONS: FLUORITAB DROPS CONTAINING SODIUM FLUORIDE (SYSTEMIC) IS INDICATED AS A DIETARY SUPPLEMENT FOR PREVENTION OF DENTAL CARIES IN CHILDREN IN THE AREAS WHERE THE LEVEL OF FLUORIDE IN DRINKING WATER IS INADEQUATE.
unapproved drug other
FLUORIDE DROPS - SODIUM FLUORIDE LIQUID FLUORITAB CORPORATION _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- FLUORITAB FLUORIDE DROPS 1 FLUID OUNCE SIZE CONTAINS: SODIUM FLUORIDE IN AN AQUEOUS VEHICLE WITH PRESERVATIVE. EACH 8 DROPS EQUIVALENT TO 1 MG. F. (FROM 2.2 MG SODIUM FLUORIDE) PPM FLUORIDE ION DAILY DOSAGE IN DRINKING WATER AGE 6 MO. – 3 YRS. AGE 3-6 YRS. AGE 6-16 YRS. LESS THAN 0.3 PPM 2 DROPS 4 DROPS 8 DROPS 0.3 TO 0.6 PPM NONE 2 DROPS 4 DROPS OVER 0.6 PPM NONE NONE NONE KEEP OUT OF REACH OF CHILDREN. CAUTION: FEDERAL (U.S.A.) LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION. CONTRAINDICATIONS: PATIENTS WITH MEDICAL CONDITION OF DENTAL FLUOROSIS. PRODUCT CATEGORY: DENTAL CARIES PROPHYLACTIC, NUTRITIONAL SUPPLEMENT (MINERAL) ACTIONS AND INDICATIONS: FLUORITAB DROPS CONTAINING SODIUM FLUORIDE (SYSTEMIC) IS INDICATED AS A DIETARY SUPPLEMENT FOR PREVENTION OF DENTAL CARIES IN CHILDREN IN THE AREAS WHERE THE LEVEL OF FLUORIDE IN DRINKING WATER IS INADEQUATE. INACTIVE INGREDIENTS: WATER, PRESERVATIVE. EXCESSIVE DOSES OF SODIUM FLUORIDE MAY RESULT IN FLUOROSIS OF TEETH IF TAKEN DURING FORMATION YEARS. FLUORITAB FLUORIDE DROPS DISTRIBUTED BY: FLUORITAB CORPORATION "BETTER TEETH - BETTER HEALTH" MUSKEGON, MI 49441 MADE IN U.S.A. FLUORIDE DROPS sodium fluoride liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:0 28 8 -5523 ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O) FLUORIDE ION 2.5 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) METHYLPARABEN (UNII: A2I8 C7HI9 T) Fluoritab Corporation PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:0 28 8 -5523-0 1 30 mL in 1 BOTTLE, DROPPER MARKETING INFORMATION MARKE TING CATE G Lire le document complet