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NDC 66885-0051-34 KELSAN Antimicrobial Ltion Skin Cleanser 0.003 mg/mL Details

KELSAN Antimicrobial Ltion Skin Cleanser 0.003 mg/mL

KELSAN Antimicrobial Ltion Skin Cleanser is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kel-San, Inc.. The primary component is CHLOROXYLENOL.

Product Information

NDC	66885-0051
Product ID	66885-051_35d13785-c0fe-4b00-99de-ffedd5b7b9c2
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	KELSAN Antimicrobial Ltion Skin Cleanser
Proprietary Name Suffix	n/a
Non-Proprietary Name	Chloroxylenol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	0.003
Active Ingredient Units	mg/mL
Substance Name	CHLOROXYLENOL
Labeler Name	Kel-San, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	n/a

Package

Package Images

NDC 66885-0051-34 (66885005134)

Pricing Information	N/A
NDC Package Code	66885-051-34
Billing NDC	66885005134
Package	1000 mL in 1 PACKAGE (66885-051-34)
Marketing Start Date	2000-06-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3cfeae6b-0b6a-4894-b8c0-85df830989cd Details

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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