Label: NEW DOCTOR AG PLUS GOLD- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 75984-001-01 - Packager: HANIL PHARMACEUTICAL CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 Label Information
Updated February 25, 2011
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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INGREDIENTS AND APPEARANCE
NEW DOCTOR AG PLUS GOLD
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75984-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.15 g in 150 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:75984-001-01 150 g in 1 CARTON 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 Business Operations HANIL PHARMACEUTICAL CO., LTD. 688197087 manufacture