REFRESH ANTIBAC FOAM- triclosan liquid 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

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)

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

ANT1L DCN9019-V2.jpg

REFRESH ANTIBAC FOAM
triclosan liquid liquid

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/15/2015	08/01/2020

Labeler - Deb USA, Inc. (607378015)

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

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

Revised: 12/2017

Document Id: 67849b1a-fa80-4946-b4ba-80b9a9b2d15e

Set id: 0e6bce16-fddc-42d1-8521-6cab2cb90f3b

Version: 3

Effective Time: 20171220

Deb USA, Inc.