REFRESH PUREBAC FOAM- chloroxylenol liquid

Refresh PureBac Foam by

Drug Labeling and Warnings

Refresh PureBac Foam by is a Otc medication manufactured, distributed, or labeled by SC Johnson Professional USA, Inc., SC Johnson Professional CA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

SCJ PROFESSIONAL
A family company™

NDC: 11084-160-27

Refresh PureBac™ FOAM

ANTIMICROBIAL FOAM SOAP
Dye & Fragrance-Free Antibacterial Foam Handwash

Stock #:PBF1L/4000000752

1 L (33.8 fl oz)

SC Johnson Professional USA, Inc.
Charlotte, NC 28217
1-800-248-7190. www.scjp.com

deb
SKIN CARE

Pat.www.scjp.com/patents

1000002970/1020

INGREDIENTS AND APPEARANCE

REFRESH PUREBAC FOAM 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	5 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
PPG-24-GLYCERETH-24 (UNII: V341SPY84U)
SODIUM LAURETH-3 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: 11084-160-27	1 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015
2	NDC: 11084-160-12	1.2 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015
3	NDC: 11084-160-20	2 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2015

Labeler - SC Johnson Professional USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
SC Johnson Professional USA, Inc.		078805627	manufacture(11084-160)