Acne Med 5% Gel
FDA Label NDC 70707-211

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Face Reality, Llc for the product Acne Med 5% (NDC 70707-211). 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 active ingredient, purpose, also contains, uses, warnings, do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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