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Drug Facts
Distributed by: D3 Development, Inc., Portland, ME 04101
Made in USA from U.S. and imported ingredients
Dermaharmony Zinc Therapy Liquid
FDA Label NDC 71819-016
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 Zinc Therapy (NDC 71819-016). 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 2%
Otc - Purpose
Purposes
Dandruff, Seborrheic dermatitis
Indications & Usage
Uses
Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.
Warnings
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have seborrheic dermatitis that covers a large portion 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 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
- Shake before each use
- Use on affected areas in place of your regular soap
- For best results use at least twice a week or as directed by a doctor
- Work up a lather using warm water and massage into affected areas
- Rinse well
Storage And Handling
Other information
- Store at room temperature
- Lot number and expiration date on bottom
Inactive Ingredient
Inactive ingredients
Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice
Otc - Questions
Questions?
1-800-827-3730
Package Label.Principal Display Panel
dermaharmony
Zinc Therapy CLEANSER
2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff
HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING
4 FL OZ (118 ml)
* Please review the disclaimer below.
