NEW DOCTOR AG PLUS GOLD- sodium monofluorophosphate paste, dentifrice 
HANIL PHARMACEUTICAL CO., LTD.

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.

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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

Image of carton

NEW DOCTOR AG PLUS  GOLD
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75984-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.15 g  in 150 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MENTHOL (UNII: L7T10EIP3A)  
PEPPERMINT (UNII: V95R5KMY2B)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SILVER (UNII: 3M4G523W1G)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
HANIL PHARMACEUTICAL CO., LTD.688197087manufacture

Revised: 2/2011
Document Id: e5506944-d50a-4086-8976-f6e608b87cf8
Set id: f7fb0742-2287-4f2b-9b5e-d1c6aaa8ec39
Version: 2
Effective Time: 20110225
 
HANIL PHARMACEUTICAL CO., LTD.