NDC 0116-0161

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 ID0116-0161_70cf3af7-7123-6510-e053-2991aa0aa5c3
NDC0116-0161
Product TypeHuman Otc Drug
Proprietary NameAntiseptic Skin Cleanser
Generic NameChlorhexidine Gluconate 4%
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2011-05-01
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 0116-0161-08

237 mL in 1 BOTTLE, PLASTIC (0116-0161-08)
Marketing Start Date2011-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0116-0161-16 [00116016116]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-05-01

NDC 0116-0161-08 [00116016108]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-05-01

NDC 0116-0161-15 [00116016115]

Antiseptic Skin Cleanser LIQUID
Marketing CategoryNDA
Application NumberNDA019125
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-01-01

Drug Details

Active Ingredients

IngredientStrength
CHLORHEXIDINE GLUCONATE4 mg/100mL

OpenFDA Data

SPL SET ID:4ab2cfc2-7adb-20c4-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211365