AFFEX ANTIMICROBIAL FOAMING HAND SO AP- chloroxylenol liquid 
Afflink, Inc.

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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AFFEX® Antimicrobial Foaming Hand Soap

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Uses

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Xylenesulfonate, Cocamide MEA, Glycerin, Isopropyl Alcohol, Lactic Acid, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Ammonium Sulfate, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, Red 4 (CI 14700), Yellow 6 (CI 15985)

Product Label

AFFEX ANTIMICROBIAL FOAMING HAND SO AP 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.003 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LACTIC ACID (UNII: 33X04XA5AT)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
JOJOBA OIL (UNII: 724GKU717M)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CORN OIL (UNII: 8470G57WFM)  
AMMONIUM SULFATE (UNII: SU46BAM238)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54057-082-421250 mL in 1 PACKAGE; Type 0: Not a Combination Product08/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/15/2013
Labeler - Afflink, Inc. (023121150)

Revised: 9/2016
Document Id: e9c68e7d-e281-4181-89fa-3ec9183131f0
Set id: 2bda3110-edf1-438f-9bd5-49b3bb1e8aa5
Version: 1
Effective Time: 20160930
 
Afflink, Inc.