NDC Code(s) : 0404-4075-01
Packager : Henry Schein, 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:0404-4075
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
(CHLORHEXIDINE - UNII:R4KO0DY52L) 		CHLORHEXIDINE GLUCONATE1.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
PEG-40 SORBITAN DIISOSTEARATE(UNII: JL4CCU7I1G)
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0404-4075-01473 mL in 1 BOTTLE Type 0: Not a Combination Product10/01/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077789 10/01/2009 09/30/2026

LABELER - Henry Schein, Inc.(012430880)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name Address ID/FEI Business Operations
Xttrium Laboratories, Inc. 007470579 manufacture(0404-4075)

PRINCIPAL DISPLAY PANEL

NDC 0404-4075-01

ACCLEAN®

CHLORHEXIDINE GLUCONATE

0.12% ORAL RINSE, USP

Anti-Microbial Rinse,

Mint

DIRECTIONS FOR USE: Fill cap to the "fill line" (15ml). 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.

KEEP OUT OF REACH OF CHILDREN

1 PINT (473 ml)

by HENRY SCHEIN ®



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 pannels while turning cap. To reseal, turn cap past "clicks" until tightly locked.

Rx Only

NDC 0404-4075-01

REF 900-4010

ACCLEAN®

CHLORHEXIDINE GLUCONATE

0.12% ORAL RINSE, USP

by HENRY SCHEIN ®

1999HS16EZCD

Descrption: 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

CAUTION, CONSULT ACCOMPANYING DOCUMENTS

Rx Only

PHARMACIST: PLEASE OPEN LEAFLET AND REMOVE.

acclean16-pdp