NDC Code(s) : 0536-1102-97, 0536-1102-59
Packager : Rugby Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rugby Antiseptic Skin CleanserCHLORHEXIDINE GLUCONATE 4% LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0536-1102
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE(UNII: MOR84MUD8E)
(CHLORHEXIDINE - UNII:R4KO0DY52L) 		CHLORHEXIDINE GLUCONATE2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLUCONOLACTONE(UNII: WQ29KQ9POT)
PEG-75 LANOLIN(UNII: 09179OX7TB)
TRIDECYL ALCOHOL(UNII: 8I9428H868)
COCO DIETHANOLAMIDE(UNII: 92005F972D)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)(UNII: S38J6RZN16)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LAURAMINE OXIDE(UNII: 4F6FC4MI8W)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0536-1102-97118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/01/2016
2NDC:0536-1102-59237 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 07/01/2016

PRINCIPAL DISPLAY PANEL

NDC 0536-1102-97

Chlorhexidine Gluconate 4% Solution

antiseptic

Distributed by:

Rugby Laboratories

Livoria, MI 48150 USA

www.rugbylaboratories.com

4RGBY04BTLLBLA

Rugby Laboratories ®

Net Wt 4 fl oz (118 mL)

Rugby 1061 4oz Page 1Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1

NDC 0536-1102-59

Chlorhexidine Gluconate 4% Solution

antiseptic

Distributed by:

Rugby Laboratories

Livoria, MI 48150 USA

www.rugbylaboratories.com

4RGBY08BTLLBLA

Rugby Laboratories ®

Net Wt 8 fl oz (237 mL)

Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1

Rugby 1061 4oz Page 1