Other
Drug Facts
Distributed by: D3 Development, Inc., Portland, ME 04101
Made in USA
Dermaharmony 10% Sulfur Soap
FDA Label NDC 71819-015
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 10% Sulfur (NDC 71819-015). 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 - do not use, 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
Sulfur 10%
Otc - Purpose
Purpose
Acne medication soap
Indications & Usage
Uses
- For the treatment of acne.
- Clears acne blemishes, blackheads, and whiteheads.
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on
- broken skin.
- large areas of the skin.
Otc - When Using
When using this product
- apply only to areas with acne.
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Otc - Stop Use
Stop use and ask a doctor if skin irritation occurs or gets worse.
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
- using warm water, wash affected area for 1-2 minutes, avoiding contact with the eyes.
- rinse thoroughly and pat dry with a clean towel.
- because excessive drying of the skin may occur start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Storage And Handling
Other information Store at room temperature in a dry place.
Inactive Ingredient
Inactive ingredients
Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, tea tree (Melaleuca alternifolia) oil, sodium chloride, coconut (Cocos nucifera) fruit extract, palm (Elaeis guineensis) fruit extract, pentasodium penetate
*May contain this ingredient
Otc - Questions
Questions?
1-800-827-3730 www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
10% Sulfur SOAP with Tea Tree Oil
For Acne Pimples, Blackheads & Whiteheads
NET WT 4 OZ (113 G)
* Please review the disclaimer below.
