KELSAN ANTIMICROBIAL LTION SKIN CLEANSER- chloroxylenol liquid
Kel-San, 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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KELSAN Antimicrobial Lotion Skin Cleanser

Active ingredient

Chloroxylenol 0.3%

Purpose

Antimicrobial

Use

• Handwash to help decrease bacteria on the skin

• Recommended for repeated use

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

• 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, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

Product Label

KELSAN ANTIMICROBIAL LTION SKIN CLEANSER
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66885-051
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Coconut Acid (UNII: 40U37V505D)
Oleic Acid (UNII: 2UMI9U37CP)
Sodium Sulfate (UNII: 0YPR65R21J)
MONOETHANOLAMINE (UNII: 5KV86114PT)
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)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66885-051-34	1000 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/30/2000	12/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/30/2000	12/31/2023

Labeler - Kel-San, Inc. (108349937)

Revised: 12/2020

Document Id: 35d13785-c0fe-4b00-99de-ffedd5b7b9c2

Set id: 3cfeae6b-0b6a-4894-b8c0-85df830989cd

Version: 2

Effective Time: 20201222

Kel-San, Inc.