DERMAHARMONY SEBORRHEIC DERMATITIS- pyrithione zinc cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Available from:
D3 Development, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Purpose Seborrheic dermatitis cream Uses - Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic dermatitis - Helps eliminate recurrence of seborrheic dermatitis Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Authorization status:
OTC monograph final
Authorization number:
71819-002-03

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

Relieves skin and/or scalp itching, irritation, redness, flaking and scaling due to seborrheic

dermatitis

Helps eliminate recurrence of seborrheic dermatitis

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

Store at 59° to 77°F (15° to 25°C)

Lot number and expiration date can be found on lid.

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)

DERMAHARMONY SEBORRHEIC DERMATITIS

pyrithione zinc cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:718 19 -0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

D3 Development, Inc.

PYRITHIO NE ZINC (UNII: R9 53O2RHZ5) (PYRITHIONE ZINC - UNII:R9 53O2RHZ5)

PYRITHIONE ZINC

0 .25 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

HYDRO XYETHYL CELLULO SE ( 18 0 0 MPA.S AT 2 %) (UNII: 6 OX6 A5C7B6 )

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

WATER (UNII: 0 59 QF0 KO0 R)

AVO CADO O IL (UNII: 6 VNO72PFC1)

GLYCERIN (UNII: PDC6 A3C0 OX)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

CASTO R O IL (UNII: D5340 Y2I9 G)

BEHENTRIMO NIUM METHO SULFATE (UNII: 5SHP745C6 1)

SHEA BUTTER (UNII: K49 155WL9 Y)

MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9 M35X2)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:718 19 -0 0 2-

8 9 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 7/26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 7/26 /20 19

Labeler -

D3 Development, Inc. (043195877)

Revised: 7/2019

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