KLENLII HAND ANTIBACTERIAL- chloroxylenol soap 
Klenlii Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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KLENLII HAND SOAP ANTIBACTERIAL

ACTIVE INGREDIENT

CHLOROXYLENOL 0.3%

PURPOSE

ANTIMICROBIAL

USES

WARNINGS

FOR EXTERNAL USE ONLY: HANDS

WHEN USING THIS PRODUCT

STOP USE AND ASK DOCTOR IF

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

INACTIVE INGREDIENTS

DEIONIZED WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, AQUEOUS CATONIC COPOLYMER, CITRIC ACID

01b LBL_Klenlii_Hand Sanii Soap_8oz

KLENLII HAND  ANTIBACTERIAL
chloroxylenol soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78016-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78016-104-18238 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
2NDC:78016-104-14118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package06/14/2020
3NDC:78016-104-16476 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
4NDC:78016-104-113785 mL in 1 JUG; Type 0: Not a Combination Product06/14/2020
5NDC:78016-104-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product06/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/14/2020
Labeler - Klenlii Company (117278596)

Revised: 6/2020
Document Id: f6aa3bb9-6ebb-4376-bdab-b9d7844d1c3a
Set id: 6781ed8d-21b0-49dc-8323-467b9b11e074
Version: 1
Effective Time: 20200614
 
Klenlii Company