NDC 68599-5401-6
API & Excipient Details

Chlorhexidine Gluconate marketed by McKesson Medical-Surgical under NDC Code 68599-5401-6

NDC Code(s) : 68599-5401-2, 68599-5401-1, 68599-5401-3, 68599-5401-7, 68599-5401-4, 68599-5401-8, 68599-5401-5, 68599-5401-9, 68599-5401-6, 68599-5401-0
Packager : McKesson Medical-Surgical

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE SOLUTION

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68599-5401
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCO DIETHANOLAMIDE(UNII: 92005F972D)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
PEG-75 LANOLIN(UNII: 09179OX7TB)
WATER(UNII: 059QF0KO0R)
TRIDECYL ALCOHOL(UNII: 8I9428H868)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68599-5401-1	48 in 1 CASE	06/01/2017
1	NDC:68599-5401-2	118 mL in 1 BOTTLE Type 0: Not a Combination Product
2	NDC:68599-5401-7	24 in 1 CASE	06/01/2017
2	NDC:68599-5401-3	237 mL in 1 BOTTLE Type 0: Not a Combination Product
3	NDC:68599-5401-8	12 in 1 CASE	06/01/2017
3	NDC:68599-5401-4	473 mL in 1 BOTTLE Type 0: Not a Combination Product
4	NDC:68599-5401-9	12 in 1 CASE	06/01/2017
4	NDC:68599-5401-5	946 mL in 1 BOTTLE Type 0: Not a Combination Product
5	NDC:68599-5401-0	4 in 1 CASE	06/01/2017
5	NDC:68599-5401-6	3800 mL in 1 BOTTLE Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019125	06/01/2017

LABELER - McKesson Medical-Surgical(023904428)

Establishment
Name	Address	ID/FEI	Business Operations
XTTRIUM LABORATORIES, INC.		007470579	manufacture(68599-5401)

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