CV MEDICATED- triclosan soap

CV Medicated by

Drug Labeling and Warnings

CV Medicated by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., STERIS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Triclosan 0.5%

Purpose

Antiseptic

Uses

• Healthcare Personnel Handwash to decrease transient bacteria 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 3 days.

When using this product

• do not get it in the eyes. 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 on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

Inactive ingredients

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?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 444 mL Bottle Label

CV®
Medicated
deb med®

NDC: 11084-805-13

REORDER #
6262-R2

Hand Soap
Lotion Soap

Moisturization

Antimicrobial

15
seconds
Fast-acting

Net Contents: 444 mL (15 fl oz)

Manufactured for:
Deb USA, Inc., Charlotte, NC 28217
1-866-783-0422
www.debmed.com

6262-14I(F)(917)
61722

INGREDIENTS AND APPEARANCE

CV MEDICATED 
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-805
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-805-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	06/01/2020
2	NDC: 11084-805-13	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	04/01/2020
3	NDC: 11084-805-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/01/2018	10/01/2020

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Corporation		139424188	MANUFACTURE(11084-805)