PUREBAC FOAM WASH- chloroxylenol liquid

PureBac Foam Wash by

Drug Labeling and Warnings

PureBac Foam Wash by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Chloroxylenol, 0.5%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses

For handwashing to reduce bacteria on the skin

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

Apply foaming cleanser to dry hands

Rub hands together to spead lather

Wash for 15-20 seconds

Rinse and dry hands thoroughly

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

deb

PureBac Foam Wash

MADE IN USA

1L

INGREDIENTS AND APPEARANCE

PUREBAC FOAM WASH 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (PHENOL - UNII:339NCG44TV)	CHLOROXYLENOL	0.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-131-20	2000 mL in 1 BOTTLE, PLASTIC
2	NDC: 11084-131-27	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2010

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture