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Derma Doctor Calm Cool and Corrected

Dosage form: gel
Ingredients: PYRITHIONE ZINC 2.0g in 100mL
Labeler: DERMAdoctor
NDC Code: 68715-291

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.

DERMAdoctor calm cool and Corrected Cleanser

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.

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.

DERMA DOCTOR CALM COOL AND CORRECTED 
pyrithione zinc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68715-291
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (PYRITHIONE ZINC) PYRITHIONE ZINC2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
PHENOXYETHANOL 
METHYLPARABEN 
ETHYLPARABEN 
PROPYLPARABEN 
BUTYLPARABEN 
ALLANTOIN 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:68715-291-021 BOTTLE, GLASS in 1 CARTON
1NDC:68715-291-01180 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/2005
Labeler - DERMAdoctor (114399392)

Revised: 06/2017
 
DERMAdoctor

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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