HIGHMARK PROFESSIONAL PINK ANTIMICROBIAL LTN SP - 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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High Mark Professional Pink Antimicrobial Lotion Soap

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Use

Handwash to help decrease bacteria on the skin

Recommended for repeated use

Directions

Wet hands

Apply a small amount of product and work into a lather

Rinse well and dry hands completely

Inactive ingredients

Water (Aqua), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Hydrolyzed Vegetable Protein, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum), Red 33 (CI 17200), Red 40 (CI 16035)

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.

For general hand washing and germ killing.


Alert Open refillable reservoir dispensers are susceptible to microbial contamination even when using antimicrobial soaps. Ideally, liquid products should be dispensed from closed, SANITARY SEALEDTM  refills. Open refillable reservoir dispensers should be washed and sanitized before every refilling. Soaps should not be added to a partially empty dispenser as this practice of "topping off" may lead to bacterial contamination of soaps and compromise the beneficial effects of hand cleaning.

Label

HIGHMARK PROFESSIONAL PINK ANTIMICROBIAL LTN SP 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61139-422
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)  
COCONUT ACID (UNII: 40U37V505D)  
OLEIC ACID (UNII: 2UMI9U37CP)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
MONOETHANOLAMINE (UNII: 5KV86114PT)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CORN OIL (UNII: 8470G57WFM)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61139-422-373785 mL in 1 JUG
2NDC:61139-422-101000 mL in 1 BOTTLE
3NDC:61139-422-202000 mL in 1 BOTTLE
4NDC:61139-422-891200 mL in 1 BOTTLE
5NDC:61139-422-901250 mL in 1 BOTTLE
6NDC:61139-422-80800 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: 59ffa252-e4ed-4b56-92ba-417e0c26f2a6
Set id: 59ffa252-e4ed-4b56-92ba-417e0c26f2a6
Version: 1
Effective Time: 20131122
 
Office Max, Inc.