DERMA DOCTOR CALM COOL AND CORRECTED- pyrithione zinc gel

Derma Doctor Calm Cool and Corrected by

Drug Labeling and Warnings

Derma Doctor Calm Cool and Corrected 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

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

Warnings

For External use only.

• Avoid contact with the eyes.  If contact occures, rinse eyes thoroughly with water. 
• 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 this product

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

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.

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 CALM COOL AND CORRECTED 
pyrithione zinc gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68715-291
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: 68715-291-02	1 in 1 CARTON	12/01/2005
1	NDC: 68715-291-01	180 mL in 1 BOTTLE, GLASS; 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)