DERMAHARMONY SEBORRHEIC DERMATITIS- pyrithione zinc cream 
D3 Development, 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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Seborrheic Dermatitis Cream

Drug Facts

Active ingredient

Pyrithione zinc 0.25%

Purpose

Seborrheic dermatitis cream

Uses

Warnings

For external use only

Ask a doctor before use if condition covers a large area of the body.

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply to affected area one to four times daily

Other information

Inactive ingredients

Water, prunus amygdalus dulcis (sweet almond) oil, persea gratissima (avocado) oil, behentrimonium methosulfate, cetyl alcohol, glycerin, coco nucifera (coconut) oil, ricinus communis (castor) oil, stearyl alcohol, beeswax, shea butter, mango seed butter, phenoxyethanol, caprylyl glycol, tocopherol (vitamin E), hydroxyethylcellulose

Questions?

1-800-827-3730

www.dermaharmony.com

Distributed by:

D3 Development, Inc.

Portland, ME 04101

dermaharmony

Seborrheic Dermatitis CREAM

Contains 0.25% Pyrithione Zinc

3 FL OZ (89 ml)

Seb Derm Cream FINAL

DERMAHARMONY SEBORRHEIC DERMATITIS 
pyrithione zinc cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
GLYCERIN (UNII: PDC6A3C0OX)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYDROXYETHYL CELLULOSE (1800 MPA.S AT 2%) (UNII: 6OX6A5C7B6)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
ALMOND OIL (UNII: 66YXD4DKO9)  
WATER (UNII: 059QF0KO0R)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
COCONUT OIL (UNII: Q9L0O73W7L)  
CASTOR OIL (UNII: D5340Y2I9G)  
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
SHEA BUTTER (UNII: K49155WL9Y)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71819-002-0389 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2019
2NDC:71819-002-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
3NDC:71819-002-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/26/2019
Labeler - D3 Development, Inc. (043195877)

Revised: 10/2020
Document Id: b29befe4-ae20-29dc-e053-2a95a90aab06
Set id: 8d81521d-9e6f-1acf-e053-2995a90a9242
Version: 2
Effective Time: 20201026
 
D3 Development, Inc.