REFRESH CLEARBAC FM- chloroxylenol liquid

Refresh ClearBac Fm by

Drug Labeling and Warnings

Refresh ClearBac Fm by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

CHLOROXYLENOL, 0.5%

Purpose

Antibacterial

Uses

for hand washing 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, PARFUM (FRAGRANCE), DIAZOLIDINYL UREA, TETRASODIUM EDTA, CITRIC ACID, METHYLPARABEN, MAGNESIUM NITRATE, PROPYLPARABEN, METHYLCHLOROISOTHIAZOLINONE, MAGNESIUM CHLORIDE, METHYLISOTHIAZOLINONE

PRINCIPAL DISPLAY PANEL

deb stoko

Refresh(TM)

ClearBac FOAM

Dye-Free Antibacterial Foam Hand Wash for General Washroom Use

Espuma antibacteriana para higiene de manos - sin colorante

ANTIBACTERIAL

Stock #

CBA1L

Made in the USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

1 L

(33.8 fl oz)

DCN9242/0916

INGREDIENTS AND APPEARANCE

REFRESH CLEARBAC FM 
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	0.50 g  in 100 mL

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 SULFATE (UNII: BPV390UAP0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
ALLANTOIN (UNII: 344S277G0Z)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 11084-003-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2016	12/31/2021
2	NDC: 11084-003-20	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2016	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/12/2016	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-003)