DERMAKLEEN- antimicrobial drug product soap

DERMAKLEEN by

Drug Labeling and Warnings

DERMAKLEEN by is a Otc medication manufactured, distributed, or labeled by Dermarite Industries LLC, DermaRite Industries, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Chloroxylenol 0.2%

Purpose:

Antimicrobial

Uses:

For handwashing to decrease bacteria on the skin.

Warnings

• For external use only.
• Avoid contact with eyes. In case of contact, flush thoroughly with water.
• Stop use and ask a doctor if irritation or redness develops.

Warnings

• Keep out of children's reach except under adult supervision. In case of accidental ingestion contact a physician or Poison Control Center rightaway.

Directions:

• Dispense into hands, wet as needed.
• Lather vigorously for at least 15 seconds
• Wash skin, rinse thoroughly and dry.

Inactive Ingredients:

Cocamide MEA, Cocamidoproplyl Betaine, Citric Acid, DMDM Hydantoin, D&C Green#6, Fragrance, Glycerin, Methylchloroisothiazolinone, Methylparaben, Methylisothiazolinone, Propylene Glycol, Propylparaben, Sodium Chloride, Sodium Hydroxide, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Tocopheryl Acetate, Water.

Questions?

Call 1-800-337-6296

Dermakleen Package Label Principal Display Panel

INGREDIENTS AND APPEARANCE

DERMAKLEEN 
antimicrobial drug product soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61924-092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.002 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61924-092-08	222 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/15/2012
2	NDC: 61924-092-01	3800 mL in 1 JUG; Type 0: Not a Combination Product	06/01/2012
3	NDC: 61924-092-34	1000 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2012
4	NDC: 61924-092-27	800 mL in 1 BAG; Type 0: Not a Combination Product	06/01/2012
5	NDC: 61924-092-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2012

Labeler - Dermarite Industries LLC (883925562)

Registrant - DermaRite Industries, LLC (883925562)

Establishment
Name	Address	ID/FEI	Business Operations
Dermarite Industries LLC		883925562	manufacture(61924-092)