Your browser does not support JavaScript! FLUORIDE DROPS (SODIUM FLUORIDE) LIQUID [FLUORITAB CORPORATION]
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FLUORIDE DROPS (sodium fluoride) liquid
[Fluoritab Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

Fluoritab Fluoride Drops label back 1oz

Fluoritab Fluoride Drops label front 1oz

FLUORIDE DROPS  
sodium fluoride liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0288-5523
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
METHYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:0288-5523-0130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/09/2011
Labeler - Fluoritab Corporation (005376702)
Registrant - Fluoritab Corporation (005376702)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories002290302manufacture, analysis
Establishment
NameAddressID/FEIBusiness Operations
Fluoritab Corporation005376702label

Revised: 05/2011
Document Id: 3a30ff5c-7903-465a-af66-21f0c24b5e3a
Set id: 2e05a9bf-f8e7-41b1-b382-2dc9d8dafee4
Version: 18
Effective Time: 20110505
 
Fluoritab Corporation

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