Moist SURE Lotion Soap

Drug Labeling and Warnings

Drug Details [pdf]

MOIST SURE- triclosan liquid 
DENTSPLY LLC, Professional Division trading as Sultan Healthcare

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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Moist SURE Lotion Soap

Drug Facts

Active ingredient

0.5% Triclosan

Purpose

Healthcare Personnel Handwash

Use

Decreases the level of transient microorganisms on the skin before contact with patients under medical care or treatment

Warnings

For external use only

Stop use and ask a doctor if irritation and redness develop and persist for more than 5 days.

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.

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 of Moist SURE Lotion Soap on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

Inactive ingredients

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

Questions or comments?

800-637-8582 201-871-1232

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

NDC: 00699-5728-08

Lotion Soap

Moist
SURE™

• Specially blended skin conditioners
• Fast acting antimicrobial including
  MRSA & VRE

REF95728
3.78 Liters (1 Gal.)

SultanHealthcare
Infection prevention.

For Healthcare Professional Use Only

MOIST SURE 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0699-5728
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)
SORBITOL (UNII: 506T60A25R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
EDETATE SODIUM (UNII: MP1J8420LU)
COCO DIETHANOLAMIDE (UNII: 92005F972D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0699-5728-08	3.78 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	07/01/2011	07/24/2019

Labeler - DENTSPLY LLC, Professional Division trading as Sultan Healthcare (167087753)

Revised: 12/2017

Document Id: b150c558-6b1f-4174-a797-c85b49936a78

34390-5

Set id: a0f0ca33-3e1d-4f7e-9c5c-fe5272189b6f

Version: 4

Effective Time: 20171227

 

DENTSPLY LLC, Profession