3 Step Acne System
FDA Label NDC 0363-3226

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product 3 Step Acne System (NDC 0363-3226). 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, uses, when using this product, keep out of reach of the children, directions, inactive ingredients, active ingredient                           purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient                      Purpose

Benzoyl Peroxide - 2.50%         Acne Treatment

Uses

• Treats and helps prevent acne blemishes.

• Treats and helps prevent acne blemishes.

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. • rinse right away with water if it gets in eyes • avoid unnecessary sun exposure and use a sunscreen •avoid contact with eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occurs, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

• 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. • rinse right away with water if it gets in eyes • avoid unnecessary sun exposure and use a sunscreen •avoid contact with eyes, lips, and mouth • avoid contact with hair and dyed fabrics, which may be bleached by this product • skin irritation may occurs, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Keep Out Of Reach Of The Children

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

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

Directions

Use morning and night. Apply a small (dime-sized) amount to dampened skin and gently massage. Rinse thoroughly with warm water. If bothersome dryness or peeling occurs, reduce application use. Follow with Refreshing Toner.

• Cleans the skin thoroughly before applying medication • Cover the entire affected area one to three times a day •  Excessive drying of the skin may occur. Start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. • If going outside, use a sunscreen.  If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive Ingredients

Water, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Sorbitol, Dimethyl Isosorbide, Disodium PEG-12 Dimethicone  Sulfosuccinate, Tridecyl Stearate, Neopentyl Glycol Dicaprylate/Dicaprate, Polyethylene, Cetyl Esters, Anthemis Nobilis Flower Extract,
Sodium Hyaluronate, Sodium PCA, Xanthan Gum, Tridecyl Trimellitate, Propylene Glycol, Imidazolidinyl Urea, Methylparaben, Propylparaben,
Fragrance

Water, Ethoxydiglycol, Cyclotetrasiloxane, Cyclopentasiloxane, Cetearyl Alcohol, Propylene Glycol, Dimethicone, lyceryl Stearate, PEG-100 Stearate, Panthenol, Allantoin, Xanthan Gum, Ceteareth-20, Carbomer, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben,
Fragrance

Active Ingredient                           Purpose

Benzoyl Peroxide - 2.50%               Acne Treatment

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