HIGHMARK PROFESSIONAL PREMIUM FOAM ANTIBACTERIAL HANDWASH- chloroxylenol liquid

Drug Labeling and Warnings

Drug Details [pdf]

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

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.

INGREDIENTS AND APPEARANCE

HIGHMARK PROFESSIONAL PREMIUM FOAM ANTIBACTERIAL HANDWASH  
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61139-513
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61139-513-10	1000 mL in 1 BOTTLE
2	NDC: 61139-513-20	2000 mL in 1 BOTTLE
3	NDC: 61139-513-89	1200 mL in 1 BOTTLE
4	NDC: 61139-513-90	1250 mL in 1 BOTTLE
5	NDC: 61139-513-80	800 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/22/2013

Labeler - Office Max, Inc. (009073099)