HIGHMARK PROFESSIONAL LUXURY FOAM ANTIBACTERIAL HANDWASH - chloroxylenol liquid 
Office Max, 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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Highmark Professional Luxury Foam Antibacterial Handwash

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin.

Recommended for repeated use.

Directions

Wet hands

Apply product and thoroughly cover hands with lather

Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Alcohol, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Propylene Glycol, Algae Extract, Aloe Barbadensis Leaf Juice, 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)

Package Label

For general hand washing and germ killing

Package Label

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.

HIGHMARK PROFESSIONAL LUXURY FOAM ANTIBACTERIAL HANDWASH 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61139-512
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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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:61139-512-101000 mL in 1 BOTTLE
2NDC:61139-512-202000 mL in 1 BOTTLE
3NDC:61139-512-891200 mL in 1 BOTTLE
4NDC:61139-512-901250 mL in 1 BOTTLE
5NDC:61139-512-80800 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/22/2013
Labeler - Office Max, Inc. (009073099)

Revised: 11/2013
Document Id: 959db8ad-9d00-4b8d-a4a9-702164db866c
Set id: 959db8ad-9d00-4b8d-a4a9-702164db866c
Version: 1
Effective Time: 20131122
 
Office Max, Inc.