NDC Code 0116-6720-04 - Chlorhexidine Gluconate

NDC Code(s) : 0116-6720-04
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:0116-6720
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
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0116-6720-04	118 mL in 1 BOTTLE Type 0: Not a Combination Product	22/08/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077789	02/01/2013

LABELER - Xttrium Laboratories, Inc.(007470579)

REGISTRANT - Xttrium Laboratories, Inc.(007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-6720)

PRINCIPAL DISPLAY PANEL

NDC 0404-6720-04

REF 112-6720

ACCLEAN ®

Chlorhexidine Gluconate

0.12% Oral Rinse, USP

Anti-Microbial Rinse,

Mint

DIRECTIONS FOR USE: Swish 1 tablespoon (15 ml) 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

1999HS04EZCD

by HENRY SCHEIN®

4 oz. (118 ml)

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.

CAUTION, CONSULT ACCOMPANYING DOCUMENTS

Rx Only

Acclean PDP