NDC Code 0116-4075-01 - Chlorhexidine Gluconate

NDC Code(s) : 0116-4075-01
Packager : Xttrium Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acclean Chlorhexidine Gluconate 0.12% Oral RinseChlorhexidine Gluconate 0.12% Oral Rinse LIQUID

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0116-4075
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
PEG-40 SORBITAN DIISOSTEARATE(UNII: JL4CCU7I1G)
GLYCERIN(UNII: PDC6A3C0OX)
ALCOHOL(UNII: 3K9958V90M)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
WATER(UNII: 059QF0KO0R)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-4075-01	473 mL in 1 BOTTLE Type 0: Not a Combination Product	10/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077789	10/01/2009

LABELER - Xttrium Laboratories, Inc.(007470579)

PRINCIPAL DISPLAY PANEL

Henry Schein

NDC 0404-4075-01

REF 900-4010

ACCLEAN ®

Chlorhexidine Gluconate

0.12% Oral Rinse, USP

Mint

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.

Rx Only

KEEP OUT OF REACH OF CHILDREN

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.

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

Made in the US

1 Pint (473 ml)

1999HS16LBLDLA

HS16 PDP