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Name:New Doctor Ag Plusgold
Manufacturer:Hanil Pharmaceutical Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:75984-001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 0.15 g  in 150 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
XYLITOL  
SODIUM LAURYL SULFATE  
MENTHOL  
PEPPERMINT  
SODIUM BENZOATE  
SILVER  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75984-001-01 150 g in 1 CARTON None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 09/01/2010

Labeler - HANIL PHARMACEUTICAL CO., LTD. (688197087)
Registrant - HANIL PHARMACEUTICAL CO., LTD. (688197087)
Establishment
Name Address ID/FEI Operations
HANIL PHARMACEUTICAL CO., LTD. 688197087 manufacture

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



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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