Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser Kit
FDA Label NDC 80861-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Acnefree, Llc for the product Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne Cleanser (NDC 80861-003). 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, use, warnings, do not use, when using this product, stop use and ask a doctor, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do Not Use

if yo u
• have very sensitive skin
• are sensitive to benzoyl peroxide

When Using This Product

• 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.
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and 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.

Stop Use And Ask A Doctor

if skin irritation becomes severe

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• use wash on entire affected area one to two times daily
• because excessive drying of the skin may occur, start with washing once daily, then gradually increase to two times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce cleansing to once a day or every other day
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• may be used on chest or back

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP,
phytosphingosine, cholesterol, carbomer, ceramide EOP

Questions Or Comments?

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