SOFTONE LUXURY FOAM ANTIBACTERIAL SKIN CLEANSER- triclosan solution

Softone Luxury Foam Antibacterial Skin Cleanser by

Drug Labeling and Warnings

Softone Luxury Foam Antibacterial Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Brady Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Triclosan Liquid 0.5% w/w

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

For External Use Only.

When using this product avoid contact with eyes; in case of contact, flush eyes with water.

Stop use & ask a doctor if irritation or redness develops and persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Wet hands and apply a palmful to hands. Scrub thoroughly for 15-20 seconds. Rinse and dry thoroughly.

Other Information

• Report serious side effects from this product to 1-877-561-6587

Ingredients

Water, Propylene Glycol, Sodium Citrate, Sodium Cumenesulfonate, Sodium Laureth Sulfate, Citric Acid, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone

Questions?

1-888-346-4652

SPL UNCLASSIFIED SECTION

Distributed in the U.S. by Brady Industries,
LLC Las Vegas, NV 89118

PRINCIPAL DISPLAY PANEL - 1 Liter Container Label

BRADY

Softone

LUXURY FOAM ANTIBACTERIAL
SKIN CLEANSER

Intended for use in restrooms
and non-processing areas only.

1 Liter
(33.8 fl oz)

NSF®

Nonfood Compounds
Program Listed E4
144823

CM1554

Triclosan Liquid 0.5%

20-14-580-0-00 / 29617

INGREDIENTS AND APPEARANCE

SOFTONE LUXURY FOAM ANTIBACTERIAL SKIN CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76279-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	5 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
Sodium Cumenesulfonate (UNII: 5798KA13PG)
Sodium Laureth Sulfate (UNII: BPV390UAP0)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-7 Glyceryl Cocoate (UNII: VNX7251543)
Edetate Disodium (UNII: 7FLD91C86K)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76279-420-12	1.2 L in 1 CONTAINER
2	NDC: 76279-420-10	1 L in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	10/01/2011

Labeler - Brady Industries LLC (034932657)