Prescribing information (package insert) - Fluoride Drops
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.
About this document
Source: FDA drug labeling via NLM DailyMed
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Drug information for Fluoride Drops
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Active ingredient |
Sodium fluoride 2.5 mg/mL
|
| Dosage form |
Liquid |
| Route |
Oral |
| Marketing status |
not in the current FDA NDC Directory |
| Company (applicant) |
Fluoritab Corporation |
| FDA approval |
UNAPPROVED DRUG OTHERUnapproved drug
|
| Manufacturers |
1 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
2.5 mg/mL – 30 ml in 1 bottle, dropper
NDC 0288-5523-01
|
|
Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
