DERMA 1 HEALTHCARE HAND WASH- chloroxylenol liquid
Woodbine Products Company

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.

----------

Drug Facts

Active Ingredient

Chloroxylenol 0.40%

Purpose

Antibacterial

Uses:

For hand washing to decrease bacteria on the skin.

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.

Directions:

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

Work until soil is emulsified.

Rinse and wipe dry.

Other Information:

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

Inactive Ingredients:

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

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

container label

DERMA 1 HEALTHCARE HAND WASH
chloroxylenol liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/14/2014	11/04/2022

Labeler - Woodbine Products Company (004220323)

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

Revised: 11/2022

Document Id: eca80051-4cae-07e3-e053-2a95a90a1403

Set id: 4658cf5d-5cbf-4223-af05-516c44ce3685

Version: 3

Effective Time: 20221104

Woodbine Products Company