FDA.reportPublic FDA data

Medicated Soft N Sure

Manufacturer
Deb USA, Inc. | STERIS Corporation
Effective date
2019-09-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:31

Label at a glance#

ProductMedicated Soft N Sure Healthcare Personnel Handwash
Active ingredientTriclosan
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Triclosan 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation and redness develop and symptoms persist for more than 3 days.

OTC - WHEN USING SECTION

When using this product do 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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

Aqua (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, Parfum (Fragrance).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11084-810-41

Medicated Soft 'N Sure®

Healthcare Personnel Handwash

ANTIMICROBIAL

1229-87

Principal Display Panel - 1 Liter Bottle Label
Principal Display Panel - 1 Liter Bottle Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11084-81011084-810-13, 11084-810-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Triclosan4NM5039Y5XACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
COCO DIETHANOLAMIDE92005F972DIACT
GLYCERINPDC6A3C0OXIACT
EDETATE SODIUMMP1J8420LUIACT
Methacrylate/Methoxy PEG-10 Maleate/Styrene Copolymer39DK5WQ2PRIACT
GELATIN HYDROLYSATE (Porcine Skin, MW 3000)0K9R94573CIACT
SODIUM CHLORIDE451W47IQ8XIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1c298787-a1c3-47d2-8bdd-e0066702a4f8fb6db121-b1aa-46c6-9092-e5e887b92d7b2019-09-27WarningsExact identifier
spl id: 1c298787-a1c3-47d2-8bdd-e0066702a4f8
spl set id: fb6db121-b1aa-46c6-9092-e5e887b92d7b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.