DEB PUREBAC FOAM WASH- chloroxylenol liquid
Deb USA, 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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Drug Facts

Active ingredient

Chloroxylenol, 0.5%

Purpose

Antibacterial

Uses

For handwashing to reduce bacteria on the skin

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact, flush with water.

Keep out of reach of children.

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

Directions

Apply foaming cleanser to dry hands

Rub hands together to spread lather

Wash for 15-20 seconds

Rinse & dry hands thoroughly

Inactive ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, PPG-24-Glycereth-24, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Cocamidopropyl Betaine, Allantoin, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Magnesium Nitrate, Propylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

deb

PureBac Foam Wash

33.8 fl. oz.

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

PBF1L

PureBacFoamWash

Rev. 08-13

product label

DEB PUREBAC FOAM WASH
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-231
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE SODIUM (UNII: MP1J8420LU)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-231-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2013	04/01/2018
2	NDC:11084-231-20	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/03/2013	04/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/03/2013	04/01/2018

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-231)

Revised: 10/2017

Document Id: 09d4ca00-a3e2-4034-ace6-9e61fbd92e17

Set id: fb3d7e73-b258-4687-acc5-6358846f3e4a

Version: 2

Effective Time: 20171024

Deb USA, Inc.