DERMA 1 HEALTHCARE HAND WASH- chloroxylenol liquid

Derma 1 Healthcare Hand Wash by

Drug Labeling and Warnings

Derma 1 Healthcare Hand Wash by is a Otc medication manufactured, distributed, or labeled by Woodbine Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Chloroxylenol 0.40%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria on the skin.

WARNINGS

Warnings:

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Apply to hands, add small amount of water and lather.

Work until soil is emulsified.

Rinse and wipe dry.

STORAGE AND HANDLING

Other Information:

Store at 20 to 25 C. (68 to 77 F)

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Propylene Glycol, Sodium Chloride, Fragrance and Glycerin.

PRINCIPAL DISPLAY PANEL

Healthcare Hand Wash

Formulated to gently cleanse, soften,

condition and protect your skin.

Contains an antiseptic ingredient,

Chloroxylenol. Ideally suited for high

risk areas where cross-contamination

is a concern. It is biodegradable,

dye-free and pH neutral to the skin.

Woodbine Products Company

915 West Smith Road

Medina, OH 44256

www.woodbineproducts.com

Made in USA

Stock #5285      1000 ml (34 fl. oz.)

Derma 1

INGREDIENTS AND APPEARANCE

DERMA 1 HEALTHCARE HAND WASH 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11429-1007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11429-1007-3	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2014
2	NDC: 11429-1007-4	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/14/2014

Labeler - Woodbine Products Company (004220323)

Establishment
Name	Address	ID/FEI	Business Operations
Woodbine Products Company		004220323	manufacture(11429-1007)