FDA Label for Medpura Benzoyl Peroxide
View Indications, Usage & Precautions
Medpura Benzoyl Peroxide Product Label
The following document was submitted to the FDA by the labeler of this product Akron Pharma 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
Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ-07004
www.akronpharma.com
Active Ingredient
Benzoyl peroxide 5%
Benzoyl peroxide 10%
Purpose
Acne treatment
Use
for the treatment of acne
Warnings
For external use only
Otc - Do Not Use
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When Using This Product
- avoid unnecessary sun exposure and use a sunscreen.
- avoid contact with eyes, lips, and mouth, eyelids and mucous membranes.
- avoid contact with hair or 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 reduced by using the product less frequently or in a lower concentration.
- 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 - 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. (1-800-222-1222)
Directions
- Shake well
- Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
- wet area to be cleansed
- apply acne wash and gently massage area for 1-2 minutes
- rinse thoroughly and pat dry
- 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 sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
Other Information
store at controlled room temperature, 15°- 30°C (59°- 86°F)
Inactive Ingredients
citric acid, edetate disodium, germall 115, glycerin, phophomer x polymer, purified water, sodium olefin sulfonate, sodium hydroxide
Questions Or Comments?
call toll-free 1-877-225-6999
Package Label.Principal Display Panel
* Please review the disclaimer below.