FDA Label for Acne Med 5%

View Indications, Usage & Precautions

Acne Med 5% Product Label

The following document was submitted to the FDA by the labeler of this product Face Reality, 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 2.5%


Purpose



For the treatment of Acne


Also Contains



Purified Water, Glycerin, Propylene Glycol, Carbomer, Sodium Hydroxide.


Uses



Adults and children 12 years and over:

For the treatment of acne.

For acne-prone or oily skin.


Warnings



For external use only. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.


Do Not Use



this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.


Directions



Apply a thin layer on affected areas. Use for 15 to 30 minutes a day at first and increase wearing time gradually until medication can be tolerated at night. slight irritation is normal and temporary. If going outside, use a sunscreen. Allow the Acne Med to dry, then follow directions in the sunscreen labelling. If irritation or sensitivity develops, discontinue use of product and consult the Clinic.


Other Information



May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.


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