SBS ULTRAGREEN- triclosan gel

SBS UltraGreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Triclosan, 0.15%

PURPOSE

Purpose

Antibacterial

INDICATIONS & USAGE

Uses

For handwashing to reduce bacteria on the skin

WARNINGS

Warnings

For external use only

Avoid contact with eyes

Keep out of reach of children

Consult with a physician or poison control center if ingested

DOSAGE & ADMINISTRATION

Directions

Apply soap to dry hands

Add water

Lather for 30 seconds

Rinse and dry

INACTIVE INGREDIENT

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

SBS UltraGreen

Antibacterial Gel

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

Proudly made in the USA

75127-01-116

1 Liter 33.8 Fluid Ounces

INGREDIENTS AND APPEARANCE

SBS ULTRAGREEN 
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.15 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
EDETATE SODIUM (UNII: MP1J8420LU)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-075-04	4000 mL in 1 BOTTLE, PLASTIC
2	NDC: 11084-075-07	2000 mL in 1 BOTTLE, PLASTIC
3	NDC: 11084-075-27	1000 mL in 1 BOTTLE, PLASTIC
4	NDC: 11084-075-54	1000 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2010

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb USA, Inc.		607378015	manufacture