FDA Label for Dermaharmony 5% Benzoyl Peroxide Cleansing Bar
View Indications, Usage & Precautions
Dermaharmony 5% Benzoyl Peroxide Cleansing Bar Product Label
The following document was submitted to the FDA by the labeler of this product D3 Development, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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)
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