Unblemish Dual Intensive Acne Treatment Lotion
FDA Label NDC 14222-2120

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 for the product Unblemish Dual Intensive Acne Treatment (NDC 14222-2120). 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 ingredients, purpose, uses, warnings, otc - when using, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzoyl Peroxide 2.5%

Purpose

Acne treatment

Uses

  • For the treatment of acne.
  • Helps keep skin clear of new acne blemishes, acne pimples, blackheads, and whiteheads.

Warnings

For external use only

Otc - When Using

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.

    • When using this product

    • 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.

Otc - Do Not Use

Do not use if you

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

Otc - Stop Use

Stop use and ask a doctor if

  • Irritation becomes severe

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • Clean the skin thoroughly before applying this product. Dispense 1-2 pumps from each side. Blend product evenly. Cover the entire affected area with a thin even layer one to three times daily. Do not rinse product off face.
  • Because 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, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Wash hands after application to help avoid staining fabrics.

Other Information

Store between 15-30°C (59-86°F).

Inactive Ingredients

Water, Ethoxydiglycol, Glycerin, Polyacrylamide, Chamomilla Recutita (Matricaria) Flower Extract, Aloe Barbadensis Leaf Juice, Allantoin, Niacinamide, Panthenol, Punica Granatum Fruit Extract, Yucca Glauca Root Extract, Ceramide AP, Ceramide EOP, Ceramide NP, Fragrance (Parfum), Biosaccharide Gum-1, Disodium Cocamido MIPA-Sulfosuccinate, Carbomer, Cholesterol, Leuconostoc/Radish Root Ferment Filtrate, Corn Starch Modified, Phytosphingosine, Sodium Lauroyl Lactylate, Xanthan Gum, Laureth-7, Aminomethyl Propanol, Disodium Oleamido MEA-Sulfosuccinate, Cl3-14 lsoparaffin, PEG-7 Glyceryl Cocoate, BHT, Disodium EDTA, Ethylhexylglycerin, Benzyl Alcohol, Phenoxyethanol, Citronellol, Geraniol, Limonene, Linalool

Questions

1-888-995-5656

Principal Display Panel - 45Ml / 1.5 Fl. Oz. Carton Label

RODAN+FIELDS

UMBLEMISH

3 Dual Intensive
Acne Treatment

RODAN+FIELDS

2 x 22.5 mL/0.76 Fl. Oz. U.S.

Principal Display Panel - 45Ml / 1.5 Fl. Oz. Tube Label

RODAN+FIELDS

UMBLEMISH

3 Dual Intensive
Acne Treatment

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