Antiseptic skin cleanser solution

Ingredients and appearance - Product information

Antiseptic skin cleanser solution- Chlorhexidine gluconate 4%

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0404-1061
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Chlorhexidine gluconate ( UNII: MOR84MUD8E)( Chlorhexidine - UNII: R4KO0DY52L ) 20 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Coco diethanolamide ( UNII: 92005F972D)
Gluconolactone ( UNII: WQ29KQ9POT)
Hydroxyethyl cellulose (2000 cps at 1%) ( UNII: S38J6RZN16)
Isopropyl alcohol ( UNII: ND2M416302)
Lauramine oxide ( UNII: 4F6FC4MI8W)
Peg-75 lanolin ( UNII: 09179OX7TB)
Water ( UNII: 059QF0KO0R)
Tridecyl alcohol ( UNII: 8I9428H868)

Product Characteristics

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0404-1061-32 946mL in 1 BOTTLE 2003/04/02
2 NDC: 0404-1061-01 3785mL in 1 BOTTLE 2003/04/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA019125 USA 2003/04/02

Labeler - Henry Schein, Inc.( 012430880)

Establishment

Name ID/FEI Business Operations
Henry Schein, Inc. 012430880 manufacture( 0404-1061)