Medicated soft n sure healthcare personnel handwash liquid

Spl unclassified section

Drug Facts

Active ingredient

0.5% Triclosan

Purpose

Antiseptic

Use

Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

Warnings

For external use only.

Otc - do not use section

Discontinue use if irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

Otc - when using section

When using this productdo not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Otc - keep out of reach of children section

Keep out of reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wet skin and spread a small amount on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

Inactive ingredients

Water, alkali salts of fatty acids, sorbitol, disodium cocoamphodiacetate, cocamide MIPA, glycerin, acrylates/PEG-10 maleate/styrene copolymer, hydrolyzed collagen, tetrasodium EDTA, sodium chloride, iodopropynyl butylcarbamate, fragrance

Questions or comments?

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Ingredients and appearance - Product information

Medicated soft n sure healthcare personnel handwash liquid- Triclosan

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 0519-1229
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Triclosan ( UNII: 4NM5039Y5X)( Triclosan - UNII: 4NM5039Y5X ) 0.5 gin 1000 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)
Disodium cocoamphodiacetate ( UNII: 18L9G3U51M)
Coco monoisopropanolamide ( UNII: 21X4Y0VTB1)
Glycerin ( UNII: PDC6A3C0OX)
Edetate sodium ( UNII: MP1J8420LU)
Methacrylate/methoxy peg-10 maleate/styrene copolymer ( UNII: 39DK5WQ2PR)
Gelatin hydrolysate (porcine skin, mw 3000) ( UNII: 0K9R94573C)
Sodium chloride ( UNII: 451W47IQ8X)
Iodopropynyl butylcarbamate ( UNII: 603P14DHEB)

Product Characteristics

Color WHITE (Off-white)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH NOT FINAL part333E USA

Labeler - STERIS Corporation( 139424188)

Establishment

Name ID/FEI Business Operations
STERIS Corporation 139424188 MANUFACTURE( 0519-1229)

Principal display panel - 1 liter bottle label

NDC 0519-1229-41

Medicated Soft 'N Sure ®

Healthcare Personnel Handwash

Net Contents: 1 Liter (33.8 fl oz) (1.05 qt)

1229-87

ANTIMICROBIAL