FDA Label for Benzoyl Peroxide

View Indications, Usage & Precautions

Benzoyl Peroxide Product Label

The following document was submitted to the FDA by the labeler of this product Geritrex 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.

Drug Facts



Active Ingredient Purpose

Benzoyl Peroxide 10% Acne Treatment


Use



For the treatment of acne


Directions



Shake well, wet face, apply to hands, add water, work into a lather, and massage gently onto face. Rinse thoroughly and pat dry

use 2 to 3 times daily or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other

day if going outside use sunscreen. After washing and drying face follow directions in the sunscreen labeling if irritation or sensitivity develops,

discontinue use of both products and consult a doctor


Warnings



For external use only

Do not use if you have very sensitive skin of if you are sensitive to benzoyl peroxide

When using this product avoid unnecessary sun exposure and use a sunscreen using other topical acne drugs at the same time or right

after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed by a

doctor. Irritation may develop, such as redness, burning, itching, peeling, or possibly swelling more frequent use or higher concentraions may

aggravate such irritation: mild irritation may be reduced by using the product less frequently or in lower concnetraion. Keep away from eyes,

lips, mouth It may bleach hair of dye fabrics

Stop use and ask a doctor if irritaion becomes severe and continue.


Inactive Ingrdients



Purified water, Carbomer, Cetearth 20 cetearyl alcohol, DMDM Hydantoin, EDTA, Peg 40 Hydrogenated castor oil, Ethyl Glycol Mono Stearate, Mineral Oil, Methyl and Propyl Paraben, Peg 200 dilurate, Glycerin, silicon oil, Stearic acid, stearyl alcohol, TEA, Magnesium aluminium silicate powder


Otc - Keep Out Of Reach Of Children



Keep out of reach of chlidren. If swallowed, get medical help or contact Poison Control Center right away


Storage And Handling



Store at room temperature 15°-30°C (59°-86°F)


Dosage & Administration



Use 2 to 3 times daily or as directed by a doctor.


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