NDC Code 0116-0175-16 - Chlorhexidine Gluconate

NDC Code(s) : 0116-0175-16
Packager : Xttrium Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Chlorhexidine GluconateChlorhexidine Gluconate RINSE

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0116-0175
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
GLYCERIN(UNII: PDC6A3C0OX)
PEG-40 SORBITAN DIISOSTEARATE(UNII: JL4CCU7I1G)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-0175-16	473 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	18/06/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077789	06/18/2009

LABELER - Xttrium Laboratories, Inc.(007470579)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0175)

PRINCIPAL DISPLAY PANEL

NDC 59883-175-16

pro-denRx

oral rinse USP

0.12% chlorhexidine gluconate

Rx Only

Keep out of reach of children

To open, press in flat panels while turning cap. Ro reseal, turn cap past "clicks" until tightly locked.

DIRECTIONS FOR USE: Fill cap to the "fill line" (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use.

INGREDIENTS: 0.12% chlorhexidine gluconate in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No. 1.

1 Pint (473 mL)

1999DM16BLDLA

Denmat 1