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Drug Facts
Distributed by:
D3 Development, Inc., Portland, ME 04101
Made in the USA
Dermaharmony Sulfur And Salicylic Acid Soap
FDA Label NDC 71819-004
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 Sulfur And Salicylic Acid (NDC 71819-004). 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 ingredients
Salicylic acid 2%
Sulfur 5%
Otc - Purpose
Purpose
Dandruff / sebhorreic dermatitis / psoriasis soap
Indications & Usage
Uses
Helps prevent and control recurrence of itching, flaking and irritation associated with dandruff, sebhorreic dermatitis, and psoriasis
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 (1-800-222-1222) right away.
Dosage & Administration
Directions
- 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.
Storage And Handling
Other information
- Store at 59° to 77°F (15° to 25°C)
- Lot number and expiration date are printed on back panel
Inactive Ingredient
Inactive ingredients
Sodium palmate, sodium cocoate*, sodium palm kernelate*, water, glycerin, soyethyl morpholinium ethosulfate (soy derived), sodium chloride, pentasodium pentetate
*May contain this ingredient
Otc - Questions
Questions?
1-800-827-3730
www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
5% Sulfur & 2% Salicylic Acid SOAP
For Dandruff, Sebhorreic Dermatitis & Psoriasis
NET WT 4 OZ (113 G)
* Please review the disclaimer below.
