DERMA DOCTOR BORN TO BE MILD CLEANSER- pyrithione zinc gel 
DERMAdoctor

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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DERMAdoctor Born to Be Mild Cleanser

Active Ingredient

Pyrithione Zinc 2%

Purpose: Controls the symptoms of seborrheic dermatitis

Use

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

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.

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

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 Dr Carton

DERMA DOCTOR BORN TO BE MILD CLEANSER 
pyrithione zinc gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68715-084
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68715-084-021 in 1 CARTON12/01/2005
1NDC:68715-084-01210 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/01/200507/31/2021
Labeler - DERMAdoctor (114399392)

Revised: 6/2021
 
DERMAdoctor