Other
Drug Facts
Distributed by:
D3 Development, Inc., Portland, ME 04101
Made in USA of U.S. and imported ingredients.
NDC Code: 71819-013-04
Dermaharmony 5% Benzoyl Peroxide Soap
FDA Label NDC 71819-013
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 5% Benzoyl Peroxide (NDC 71819-013). 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
Benzoyl peroxide 5%
Otc - Purpose
Purpose
Acne medication
Indications & Usage
Use
for the management of acne
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
Otc - When Using
When using this product
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- 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.
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Otc - Stop Use
Stop use and ask a doctor if irritation becomes severe.
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
- rinse thoroughly and pat dry with a clean towel
- start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Storage And Handling
Other information
Store in a dry place between 59-86°F (15-30°C)
Inactive Ingredient
Inactive ingredients
Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, iron oxides (red and yellow), lactic acid
Otc - Questions
Questions?
1-800-827-3730
www.dermaharmony.com
Package Label.Principal Display Panel
dermaharmony
5% Benzoyl Peroxide
Cleansing Bar
FOR THE TREATMENT OF ACNE
Reduces: pimples-blemishes-whiteheads-blackheads
NET WT 4 OZ (113G)
* Please review the disclaimer below.
