Drug Facts
Active Ingredient Purpose
Benzoyl Peroxide 10% Acne Treatment
Benzoyl Peroxide
FDA Label NDC 54162-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Benzoyl Peroxide (NDC 54162-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, use, directions, warnings, inactive ingrdients, otc - keep out of reach of children, storage and handling, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
* Please review the disclaimer below.
