Other
Drug Facts
Distributed by:
D3 Development, Inc., Portland, ME 04101
Made in USA of U.S. and imported ingredients.
NDC Code: 71819-018-04
Dermaharmony Tea Tree Bar Shampoo
FDA Label NDC 71819-018
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 Tea Tree Bar (NDC 71819-018). 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
Purpose
Dandruff / seborrheic dermatitis shampoo
Indications & Usage
Uses
Controls and reduces the symptoms of dandruff and seborrheic dermatitis.
Warnings
Warnings
For external use only
Otc - Ask Doctor
Ask a doctor before use if you have a condition that 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 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
- Use on affected areas in place of your regular shampoo
- For best results use at least twice a week or as directed by a doctor
- Rub between hands to create a lather, or apply bar directly onto hair
- Massage into the hair and scalp for 60-90 seconds, then rinse well
Storage And Handling
Other information
- Store at room temperature
Inactive Ingredient
Inactive ingredients
Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).
Otc - Questions
Questions?
1-800-827-3730
www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
TEA TREE Shampoo Bar
with 2% Pyrithione Zinc
FOR DANDRUFF & SEBORRHEIC DERMATITIS
NET WT 4 OZ (113G)
* Please review the disclaimer below.
