Unblemish
FDA Label NDC 14222-2000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields, Llc for the product Unblemish (NDC 14222-2000). 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, active ingredient, purpose, uses, warnings, do not use if you, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne treatment

Uses

  • For the treatment of acne.
  • Penetrates pores to control acne blemishes, pimples and blackheads.
  • Helps prevent new acne blemishes, pimples and blackheads from forming.

Warnings

​For external use only.

Do Not Use If You

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

When Using This Product

  • Skin irritation and dryness are 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 combination.

Otc - Stop Use

Stop use and ask a doctor if irritation becomes severe.

Keep Out Of Reach Of Children.

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

Directions

  • Cleanse skin thoroughly before applying this product.
  • Dispense 1-2 pumps from each side.  Blend product and apply evenly over the entire face, avoiding the eye area.  Allow to penetrate skin.  Do not rinse off.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to twice daily as needed or as directed by a doctor.  If bothersome dryness or peeling occur reduce application to once a day or every other day and apply a moisturizer.
  • If going outside, apply sunscreen after using this product.  If irritation or sensitivity develop, stop use of both products and ask a doctor.

Other Information

You may report a serious adverse reaction to Rodan+Field​s®​, Attn: Product Development, 60 Spear Street, Suite 600, San Francisco, CA 94105.

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Biosaccharide Gum-1, Carbomer, C13-14 Isoparaffin, Ceramide AP, Ceramide EOP, Ceramide NP, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Disodium EDTA, Disodium Oleamido MEA Sulfosuccinate, Glycerin, Laureth-7, Niacinamide, Panthenol, Phytosphingosine, Polyacrylamide, Punica Granatum Extract, Purified Water, Sodium Lauroyl Lactylate, Xanthan Gum, Yucca Glauca Root Extract

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Rodan+Fields

Unblemish

Dual Intensive Acne Treatment

2 X 22.5 mL/0.76 Fl. Oz.

Rfunblemish (Rfunblemish)

Rfunblemish (Rfunblemish)

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