DERMOPLUS MEDICATED- triclosan soap
Viny Health and Beauty 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.

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ACTIVE INGREDIENTS

TRICLOSAN 0.3%

PURPOSE

ANTIMICROBIAL

Keep out of reach of children.

USES:

FOR TREATMENT AND PREVENTION OF SCABIES, ECZEMA AND SKIN RASHES.

WARNING: DERMOPLUS MEDICATED SOAP IS SAFE FOR ALL OF THE FAMILY. HOWEVER, IF THERE IS ANY ADVERSE REACTION, STOP USE IMMEDIATELY. PLEASE REFER ANY SKIN CARE QUESTIONS TO YOUR FAMILY DOCTOR OR PHARMCIST.

DIRECTIONS:

USE REGULARLY MORNING AND NIGHT INSTEAD OF YOUR NORMAL SOAP. WASH ALL OVER WITH A GOOD LATHER. RINSE OFF WITH FRESH WATER AND REPEAT. DRY YOUR SKIN WITH A CLEAN TOWEL. FOLLOW THIS ROUTINE UNTIL THE INFECTION IS TOTALLY CLEAR.

INACTIVE INGREDIENTS:

MONOSULFIRAM, SODIUM COCOATE, SODIUM PALM KERNELATE, SODIUM PALMITATE, SODIUM PALMITATE, WATER.

DERMOPLUS Final

DERMOPLUS MEDICATED
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76436-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SULFIRAM (UNII: 1XHL4Q8P7Y)
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM PALMITATE (UNII: JQ43KP6296)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76436-101-13	85 g in 1 BOX; Type 0: Not a Combination Product	03/22/2014	10/26/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/22/2014	10/26/2017

Labeler - Viny Health and Beauty Inc (963374942)

Revised: 10/2017

Document Id: 67d01b11-fe59-4258-ada4-33879bb5f350

Set id: 6bba740c-bab4-4c05-9ce1-67000c4954b6

Version: 4

Effective Time: 20171026

Viny Health and Beauty Inc