NDC 0116-0237

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4%

Antiseptic Skin Cleanser is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Xttrium Laboratories, Inc.. The primary component is Chlorhexidine Gluconate.

Product ID0116-0237_7599e169-c459-72c5-e053-2991aa0aaf29
NDC0116-0237
Product TypeHuman Otc Drug
Proprietary NameAntiseptic Skin Cleanser
Generic NameChlorhexidine Gluconate 4%
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2014-02-20
Marketing CategoryNDA / NDA
Application NumberNDA019125
Labeler NameXttrium Laboratories, Inc.
Substance NameCHLORHEXIDINE GLUCONATE
Active Ingredient Strength4 mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0116-0237-01

237 mL in 1 BOTTLE, PLASTIC (0116-0237-01)
Marketing Start Date2014-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0116-0237-01 [00116023701]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-02-20

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE4 mg/100mL

OpenFDA Data

SPL SET ID:4a65dfa5-5470-0983-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211365