FDA Label for Benzoyl Peroxide
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS:
- DO NOT USE IF YOU
- WHEN USING THIS PRODUCT
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 5% 5OZ (148 G) BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 5% 8OZ (237 G) BOTTLE LABEL
- PRINCIPAL DISPLAY PANEL - 10% 5OZ (148 G) BOTTLE LABEL
- PRINICIPAL DISPLAY PANEL - 10% 8OZ (237 G) BOTTLE LABEL
Benzoyl Peroxide Product Label
The following document was submitted to the FDA by the labeler of this product Burel Pharmaceuticals, Llc. 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.
Active Ingredient
benzoyl peroxide USP, 5% or 10%
Purpose
Acne medication
Use
- For the treatment of acne
Warnings:
For external use only.
- Avoid contact with eyes, eyelids, lips and mucous membranes.
Do Not Use If You
- have very sensitive skin
- are sensitive to benzoyl peroxide
When Using This Product
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid contact with eyes, lips, and mouth.
- 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.
- Stop use and ask a doctor if irritation becomes severe.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
SHAKE WELL.
- Clean the skin thoroughly before applying this product.
- 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.
- One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, 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.
- Follow directions in the sunscreen labeling.
- 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
Carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.
Principal Display Panel - 5% 5Oz (148 G) Bottle Label
NDC 35573-453-91
BENZOYL
PEROXIDE
TOPICAL
WASH 5%
FOR TOPICAL USE ONLY
Net Weight 5 oz
(148 g)
burelpharma
Principal Display Panel - 5% 8Oz (237 G) Bottle Label
NDC 35573-453-08
BENZOYL
PEROXIDE
TOPICAL
WASH 5%
FOR TOPICAL USE ONLY
Net Weight 8 oz
(237 g)
burelpharma
Principal Display Panel - 10% 5Oz (148 G) Bottle Label
NDC 35573-454-91
BENZOYL
PEROXIDE
TOPICAL
WASH 10%
FOR TOPICAL USE ONLY
Net Weight 5 oz
(148 g)
burelpharma
Prinicipal Display Panel - 10% 8Oz (237 G) Bottle Label
NDC 35573-454-08
BENZOYL
PEROXIDE
TOPICAL
WASH 10%
FOR TOPICAL USE ONLY
Net Weight 8 oz
(237 g)
burelpharma
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