DERMAHARMONY SEBORRHEIC DERMATITIS- pyrithione zinc cream

Dermaharmony Seborrheic Dermatitis by

Drug Labeling and Warnings

Dermaharmony Seborrheic Dermatitis by is a Otc medication manufactured, distributed, or labeled by D3 Development, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Pyrithione zinc 0.25%

PURPOSE

Purpose

Seborrheic dermatitis cream

INDICATIONS & USAGE

Uses

• Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis
• Helps eliminate recurrence of seborrheic dermatitis

WARNINGS

Warnings

For external use only

ASK DOCTOR

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

Directions

Apply to affected area one to four times daily

STORAGE AND HANDLING

Other information

• Store at 59° to 77°F (15° to 25°C)
• Lot number and expiration date can be found on lid.

INACTIVE INGREDIENT

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

Questions?

1-800-827-3730

www.dermaharmony.com

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Distributed by:

D3 Development, Inc.

Portland, ME 04101

PRINCIPAL DISPLAY PANEL

dermaharmony

Seborrheic Dermatitis CREAM

Contains 0.25% Pyrithione Zinc

3 FL OZ (89 ml)

INGREDIENTS AND APPEARANCE

DERMAHARMONY SEBORRHEIC DERMATITIS 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71819-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
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)
GLYCERIN (UNII: PDC6A3C0OX)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71819-002-03	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/26/2019

Labeler - D3 Development, Inc. (043195877)