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Drug Facts
Distributed by:
D3 Development, Inc.
Portland, ME 04101
Dermaharmony Seborrheic Dermatitis Cream
FDA Label NDC 71819-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by D3 Development, Inc. for the product Dermaharmony Seborrheic Dermatitis (NDC 71819-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Pyrithione zinc 0.25%
Otc - 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
Otc - Ask Doctor
Ask a doctor before use if condition covers a large area of the body.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
Otc - Stop Use
Stop use and ask a doctor if condition worsens or does not improve after regular use of the product as directed.
Otc - 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
Otc - Questions
Questions?
1-800-827-3730
www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
Seborrheic Dermatitis CREAM
Contains 0.25% Pyrithione Zinc
3 FL OZ (89 ml)
* Please review the disclaimer below.
