REFRESH ANTIBAC FOAM- triclosan liquid liquid

Refresh AntiBac Foam by

Drug Labeling and Warnings

Refresh AntiBac Foam by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Deb Worldwide Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

TRICLOSAN, 0.30%

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 and dry hands thoroughly

Inactive ingredients

AQUA (WATER), SODIUM LAURETH SULFATE, PROPYLENE GLYCOL, PEG-7 GLYCERYL COCOATE, GLYCERIN, COCAMIDOPROPYL BETAINE,
2-BROMO-2-NITROPROPANE-1,3-DIOL, PARFUM (FRAGRANCE), CITRIC ACID, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, GREEN 5 (CI 61570), YELLOW 5 (CI 19140)

PRINCIPAL DISPLAY PANEL

deb stoko

Refresh

AntiBac FOAM

EN Pleasantly Perfumed Antibacterial Foam Handwash

ES Espuma antibacteriana y perfumada para higiene de manos

ANTIBACTERIAL

deb

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com

1 L

33.8 fl oz

DCN9019/0315

INGREDIENTS AND APPEARANCE

REFRESH ANTIBAC FOAM 
triclosan liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
BRONOPOL (UNII: 6PU1E16C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-100-40	0.4 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015	08/01/2020
2	NDC: 11084-100-27	1 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015	08/01/2020
3	NDC: 11084-100-12	1.2 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015	08/01/2020
4	NDC: 11084-100-20	2 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015	08/01/2020
5	NDC: 11084-100-99	1230 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 1: Convenience Kit of Co-Package	04/15/2015	08/01/2020
6	NDC: 11084-100-06	1.6 L in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	04/15/2015	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2015	08/01/2020

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		078805627	manufacture(11084-100)

Establishment
Name	Address	ID/FEI	Business Operations
Deb Worldwide Healthcare Inc.		205662831	repack(11084-100)