FDA Label for Micronized Benzoyl Peroxide Treatment
View Indications, Usage & Precautions
Micronized Benzoyl Peroxide Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Pharmco Laboratories 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
- If swallowed get medical help or call a poison control center immediately
- Keep away from excessive heat or heat sources
Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
www.pharmcolabs.com • 1.800.635.0712 • Reorder CT07-2
Active Ingredient
Benzoyl Peroxide 2.5%
Indications & Usage
Acne Treatment
Uses
- For the treatment of acne
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
- 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.
- Avoid unnecessary sun exposure and use a sunscreen
- Avoid contact with the eyes, lips, and mouth
- Avoid contact with hair and dyed fabrics, which may be bleached by this product
- Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be erduced by using the product less frequently or in a lower concentartion.
- If going outside, apply sunscreen after using this product.
Otc - Stop Use
- If sensitivity develops or irritation becomes severe, stop use and ask a doctor.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children
Directions
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.
- If going outside, apply broad spectrum sunscreen SPF 15 or higher.
Other Ingredients
Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water.
Other Information
Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.
Principal Display Panel - 59 G Tube Label
PHARMCO
SKINCARE LABS
Micronized
Benzoyl Peroxide
Treatment Gel
2.5%
Net wt. 2 oz. (59 g)
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