ECOLAB- triclosan solution
Ecolab 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 0.3%

Purpose

Antiseptic Handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

For external use only.

Do not use

in eyes

When using this product

discontinue use if irritation and redness develop

Stop use and ask a physician if

skin irritation or redness occurs for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands with warm water
Apply hand soap
Rub vigorously for 30 seconds
Wash between fingers, around fingernails and backs of hands
Rinse thoroughly with warm water
Dry with paper towels or air-dry

Other information

For additional information, see Safety Data Sheet (SDS).
For emergency medical information, call 866.897.8061.

Inactive ingredients

water (aqua), potassium cocoate, sodium laureth sulfate, alcohol, hexylene glycol, boric acid, cocamidopropyl PG-dimonium chloride phosphate, hydroxyethylcellulose, tetrasodium EDTA, PEG-75 lanolin, cocamine oxide, fragrance, methylparaben, propylparaben, aloe barbasensis leaf juice, FDC yellow 5, red 4, tert-butyl alcohol, denatonium benzoate

Questions? call 1.866.444.7450

Representative label with PDP

Member's Mark

QUALITY GUARANTEED

COMMERCIAL

FROM

ECOLAB®

ANTIBACTERIAL

HAND SOAP

KILLS 99.9% OF GERMS•

NET CONTENTS 1 GALLON(3.78 L)

representative label

ECOLAB
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:47593-510
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
POTASSIUM COCOATE (UNII: F8U72V8ZXP)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BORIC ACID (UNII: R57ZHV85D4)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
edetate sodium (UNII: MP1J8420LU)
PEG-75 LANOLIN (UNII: 09179OX7TB)
COCAMINE OXIDE (UNII: QWA2IZI6FI)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE (UNII: V5VD430YW9)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:47593-510-11	3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/03/2015	09/30/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/03/2015	09/30/2018

Labeler - Ecolab Inc. (006154611)

Revised: 3/2018

Document Id: 3ef6932b-9b6b-40f4-a196-fdfa5f11e16d

Set id: fc7f65b3-3953-4188-8d73-fb25350872e2

Version: 2

Effective Time: 20180323

Ecolab Inc.