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FDA Approval

Antiseptic Skin Cleanser

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 30, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Chlorhexidine(4 mg in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Antiseptic Skin Cleanser

Product Details

NDC Product Code
0116-0137
Application Number
NDA019125
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
April 30, 2025
COCO DIETHANOLAMIDEInactive
Code: 92005F972DClass: IACT
PEG-75 LANOLINInactive
Code: 09179OX7TBClass: IACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLUCONOLACTONEInactive
Code: WQ29KQ9POTClass: IACT
TRIDECYL ALCOHOLInactive
Code: 8I9428H868Class: IACT
Code: MOR84MUD8EClass: ACTIBQuantity: 4 mg in 100 mL
LAURAMINE OXIDEInactive
Code: 4F6FC4MI8WClass: IACT
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