NEW DOCTOR AG PLUS GOLD

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 0.15g in 150g
Labeler: HANIL PHARMACEUTICAL CO., LTD.
NDC Code: 75984-001

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.

Drug Facts

ACTIVE INGREDIENT: Sodium Monofluorophosphate

INACTIVE INGREDIENTS:

D-Sorbitol, Glycerin, Sodium  Saccharin, Chitosan, Xylitol, Sodium Lauryl Sulfate, Menthol, Peppermint, Sodium Benzoate, Green tea extract, Sodium Carboxyl Cellulose,
Siver, Water, Triclosan, Siliccon Dioxide

PURPOSE: ANTICAVITY

WARNINGS:
WHEN USING THIS PRODUCT DO NOT USE FOR SENSITIVITY LONGER THAN FOUR WEEKS UNLESS RECOMMENDED BY A DENTIST.
STOP USE AND ASK A DENTIST IF THE SENSITIVITY PROBLEM PERSISTS OR WORSENS.
SENSITIVE TEETH MAY NEED PROMPT CARE.

KEEP OUT OF REACH OF CHILDREN:

IF ACCIDENTALLY SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INDICATION AND USAGE:

ADULTS AT LEAST A HALF-INCH STRIP OF THE PRODUCT ONTO A SOFT BRISTLED TOOTH BRUSH.
BRUSH TEETH THOROUGHLY FOR AT LEAST 3 MINUTES TWICE A DAY (MORNING AND EVENING)
UNDER 12 YRS: ASK A DENTIST

DOSAGE AND ADMINISTRATION:

ADULTS AT LEAST A HALF-INCH STRIP OF THE PRODUCT ONTO A SOFT BRISTLED TOOTH BRUSH.
BRUSH TEETH THOROUGHLY FOR AT LEAST 3 MINUTES TWICE A DAY (MORNING AND EVENING)
UNDER 12 YRS: ASK A DENTIST

NEW DOCTOR AG PLUS  GOLD
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75984-001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE0.15 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
SODIUM LAURYL SULFATE 
MENTHOL 
PEPPERMINT 
SODIUM BENZOATE 
SILVER 
WATER 
Packaging
#Item CodePackage Description
1NDC:75984-001-01150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/01/2010
Labeler - HANIL PHARMACEUTICAL CO., LTD. (688197087)
Registrant - HANIL PHARMACEUTICAL CO., LTD. (688197087)
Establishment
NameAddressID/FEIOperations
HANIL PHARMACEUTICAL CO., LTD.688197087manufacture

Revised: 02/2011
 
HANIL PHARMACEUTICAL CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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