NDC Code(s) : 0404-6720-04
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:0404-6720
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:0404-6720-04118 mL in 1 BOTTLE Type 0: Not a Combination Product22/08/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077789 02/01/2013 05/31/2026

LABELER - Henry Schein, Inc.(012430880)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name Address ID/FEI Business Operations
Xttrium Laboratories, Inc. 007470579 manufacture(0404-6720)

PRINCIPAL DISPLAY PANEL

NDC 0404-6720-04

HENRY SCHEIN ®

ACCLEAN®

CHLORHEXIDINE GLUCONATE

0.12% ORAL RINSE, USP

Mint Flavored

REF 112-6720

DIRECTIONS FOR USE: Swish one tablespoon (15ml) 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

Made in the US

Rx Only

4 oz. (118 ml)

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