La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine Kit
FDA Label NDC 49967-282

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 Effaclar Dermatological Acne System 3 Step Acne Routine (NDC 49967-282). 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 effaclar medicated gel cleanser, active ingredient, purpose, use, warnings, when using this product, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Effaclar Medicated Gel Cleanser

Drug Facts

Active Ingredient

Salicylic acid 2%

Salicylic acid 0.5%

Benzoyl peroxide 5.5%

Purpose

Acne treatment

Acne treatment

Acne medication

Use

for the treatment of acne

for the treatment of acne

Warnings

For external use only

For external use only

For external use only

When Using This Product

  • skin irritation and dryness is more liekly 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.
  • 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.

    • 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

Keep Out Of Reach Of Children.

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

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

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

Directions

  • use twice daily
  • wet face, then work product into a lather
  • massage onto face avoiding the eyes
  • rinse well
    • clean the skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • 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
      • cleanse the skin thoroughly before applying this product
      • cover the entire affected area with a thin layer one to three times daily
      • 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.

Inactive Ingredients

water, sodium laureth sulfate, decyl glucoside, glycerin, sodium chloride, coco-betaine, sodium hydroxide, PEG-150 pentaerythrityl tetrastearate, citric acid, hexylene glycol, PEG-6 caprylic/capric glycerides, zinc gluconate, tetrasodium EDTA, polyquaternium-47, menthol, capryloyl salicylic acid, sodium benzoate

water, alcohol denat., propanediol, glycolic acid, sodium hydroxide, capryloyl glycine, phenoxyethanol, benzyl alcohol, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, menthol, tremella fuciformis polysaccharide, butylene glycol, ophiopogon japonicus root extract, scutellaria baicalensis root extract

Questions Or Comments?

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1-888-LRP-LABO 1-888-577-5226

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Effaclar Clarifying Solution

Drug Facts

Other Information

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing and limit sun exposure while using this product and for a week afterwards.

store at 20° - 25°C (68° - 77°F)

Effaclar Duo Dual Action Acne Treatment

Drug Facts

Uses

  • for the treatment of acne
  • dries and clears acne blemishes and allows skin to heal

Do Not Use If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If

irritation becomes severe

Ingredients

water, isostearyl alcohol, glycerin, pentylene glycol, silica, carbomer, capryloyl salicylic acid, potassium hydroxide, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, epilobium angustifolium flower/leaf/stem extract

Package Label.Principal Display Panel

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