La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser Liquid
FDA Label NDC 49967-647

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by L'oreal Usa Products Inc for the product La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication Cleanser (NDC 49967-647). 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, warnings, do not use if you, when using this product, stop use and ask a doctor if, 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 Ingredient

Benzoyl peroxide 4.0%

Purpose

Acne treatment

Uses

  • for the treatment of acne
  • helps clear up blemishes and allows skin to heal

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 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

irritation becomes severe

Keep Out Of Reach Of Children.

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

Directions

• apply a dime-size amount to damp skin

• gently massage, avoiding the eye area

• rinse well

• use cleanser on entire affected area, every morning and evening

• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Inactive Ingredients

water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, potassium hydroxide, sodium chloride, sodium citrate, niacinamide, sodium hyaluronate, capryloyl salicylic acid, propanediol, diethylhexyl sodium sulfosuccinate, carbomer, benzoic acid, pentylene glycol, sodium hydroxide, glycolic acid, tetrasodium EDTA, trisodium ethylenediamine disuccinate, citric acid

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