SBS ULTRAGREEN- triclosan 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, 0.15%

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 soap to dry hands

Add water

Lather for 30 seconds

Rinse and dry

Inactive ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, Propylene Glycol, Cocamidopropyl Betaine, Chloroxylenol, Tetrasodium EDTA, Citric Acid, Fragrance, Sodium Hydroxide, Magnesium Nitrate, Acrylic Copolymer, Methylchloroisothiazolinone, Magnesium Chloride, Methylisonthiazolinone, Green 5 (CI 61570), Yellow 5 (CI 19140).

SBS UltraGreen

Antibacterial Gel

Ideal for Healthcare, Food Service, Office Environments, Schools, Professional Buildings

deb

Made in USA

Deb USA, Inc.

Charlotte, NC 28217

1-800-248-7190

www.debgroup.com.

75127

1 Liter

33.8 Fluid Ounces

Rev. 07-13

product label

SBS ULTRAGREEN
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11084-175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1.5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11084-175-27	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2013	08/01/2020
2	NDC:11084-175-07	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2013	08/01/2020
3	NDC:11084-175-05	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2013	08/01/2020
4	NDC:11084-175-04	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2013	08/01/2020
5	NDC:11084-175-54	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2013	08/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/25/2013	08/01/2020

Labeler - Deb USA, Inc. (607378015)

Name	Address	ID/FEI	Business Operations
Establishment
Deb USA, Inc.		078805627	manufacture(11084-175)

Revised: 11/2017

Document Id: 6fc3086c-28fa-4df3-b1cd-61e1536fb412

Set id: 6c1667f8-218e-4cd1-8ea4-5b5dc23695d3

Version: 2

Effective Time: 20171106

Deb USA, Inc.