DERMA DOCTOR BORN TO BE MILD CLEANSER- pyrithione zinc gel

Derma Doctor Born to be Mild Cleanser by

Drug Labeling and Warnings

Derma Doctor Born to be Mild Cleanser by is a Otc medication manufactured, distributed, or labeled by DERMAdoctor . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Pyrithione Zinc 2%

Purpose: Controls the symptoms of seborrheic dermatitis

INDICATIONS & USAGE

Use

Controls itching irritation, redness and flaking associated with seborrheic dermatitis.

WARNINGS

Warnings For External use only.  Do not get into eyes.  Rinse with water to remove.  If condition worsens or does not improve after regular use of this product as directed, consult a physician.  If condition covers a large area of the body consult your doctor before using the product.

KEEP OUT OF REACH OF CHILDREN

Directions

Use on affected area in the place of your regular soap.  Apply to wet skin.  Create a rich lather using warm water and massage gently.  Rinse well.  For best results use at least twice a week or as directed by a doctor.

Store at controlled room temperature 59 - 86F / 15 -30C

INACTIVE INGREDIENT

Other Ingredients:

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Peg-7 Glyceryl cocoate, Polyqauternium-7, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, PEG-12 Dimethicone, Sodium Hydroxide, Phenoxyethanol,  Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMA DOCTOR BORN TO BE MILD CLEANSER 
pyrithione zinc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68715-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALLANTOIN (UNII: 344S277G0Z)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68715-084-02	1 in 1 CARTON	12/01/2005
1	NDC: 68715-084-01	210 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/01/2005

Labeler - DERMAdoctor (114399392)