ECOLAB DIGICLEAN- triclosan solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)
Available from:
Ecolab Inc.
INN (International Name):
TRICLOSAN
Composition:
TRICLOSAN 3 mg in 1 mL
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic handwash - for handwashing to decrease bacteria on the skin
Authorization status:
OTC monograph not final
Authorization number:
47593-307-41, 47593-307-59

ECOLAB DIGICLEAN- 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.

----------

Drug Facts

Active Ingredient

Triclosan, 0.3%

Purpos e

Antiseptic handwash

Us es

for handwashing to decrease bacteria on the skin

Warnings

For external use only

Do not use

In eyes

When using this product

if in eyes, rinse promptly and thoroughly with water discontinue use if irritation and redness develop

Stop use and ask a doctor 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 and apply foam

Scrub hands and forearms

Rinse thoroughly and dry

Other information

For additional information, see Safety Data Sheet (SDS)

For emergency medical information in USA and Canada, call 1-800-328-0026

For emergency medical information worldwide, call 1-651-222-5352 (in the USA)

Inactive Ingredients

water (aqua), potassium cocoate, SD alcohol 40-B, sodium laureth sulfate, hexylene glycol, boric acid,

cocamidopropyl PG dimonium chloride phosphate, tetrasodium EDTA, PEG 75 lanolin, cocamine

oxide, fragrance, t-butyl alcohol, methylparaben, propylparaben, aloe barbadensis, FD&C blue 1,

denatonium benzoate

denatonium benzoate

Ques tions ?

Call 1-800-35-CLEAN (352-5326)

Principal display panel and representative label

DIN 02242846

ECOLAB

23672

6123672

DigiClean™

Anti-bacterial Foam Hand Soap

750 mL (25 US FL OZ)

Active Ingredient:

Triclosan, 0.3%

706130/5401/0117

This product may be patented | Ce produit peut être breveté | Este producto puede ser

patentado: www.ecolab.com/patents

Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA · tel: 1 800 35 CLEAN (352 5326)

5105 Tomken Road · Mississauga ON L4W 2X5 Canada

© 2017 Ecolab USA Inc · All rights reserved | Tous droits réservés | Todos los

derechos reservados

Made in U.S.A. | Fabriqué aux É-U | Hecho en EE.UU

www.ecolab.com · 706130/5405/0117

ECOLAB DIGICLEAN

triclosan solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4759 3-30 7

Route of Administration

TOPICAL

Ecolab Inc.

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)

TRICLOSAN

3 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PO TASSIUM CO CO ATE (UNII: F8 U72V8 ZXP)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )

HEXYLENE GLYCO L (UNII: KEH0 A3F75J)

BO RIC ACID (UNII: R57ZHV8 5D4)

CO CAMIDO PRO PYL PG-DIMO NIUM CHLO RIDE PHO SPHATE (UNII: H2KVQ74JM4)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

PEG-7 5 LANO LIN (UNII: 0 9 179 OX7TB)

CO CAMINE O XIDE (UNII: QWA2IZI6 FI)

TERT-BUTYL ALCO HO L (UNII: MD8 3SFE9 59 )

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:4759 3-30 7-

750 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/26 /19 9 9

2

NDC:4759 3-30 7-

1250 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 5/26 /19 9 9

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333E

0 5/26 /19 9 9

Labeler -

Ecolab Inc. (006154611)

Revised: 4/2017

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