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 spead lather

Wash for 15-20 seconds

Rinse and 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, Fragrance, Tetrasodium EDTA, Diazolidinyl Urea, Citric Acid, Methylparaben, Magnesium Nitrate, Propylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone.

deb

PureBac Foam Wash

MADE IN USA

1L

container label

PUREBAC FOAM WASH 
chloroxylenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-131
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (PHENOL - UNII:339NCG44TV) CHLOROXYLENOL0.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE 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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11084-131-202000 mL in 1 BOTTLE, PLASTIC
2NDC:11084-131-271000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/01/2010
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
Deb USA, Inc.607378015manufacture

Revised: 9/2010
Document Id: 90e910b6-bf3e-4462-a17e-d6c45d85b44c
Set id: 2c0fd9af-f64c-45c6-8ff7-f16e13145d96
Version: 1
Effective Time: 20100911
 
Deb USA, Inc.