La Roche Posay Laboratoire Dermatologique Benzoyl Peroxide Effaclar Bpo Cream
FDA Label NDC 82046-884

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 Benzoyl Peroxide Effaclar Bpo (NDC 82046-884). 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 5.5%

Purpose

Acne treatment

Uses

  • for the treatment of acne
  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes 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 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

  • 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 mayoccur, start with one application daily, thengradually increase to two or three timesdaily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs,reduce application to once a day or everyother day
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

  • store at room temperature 68°-77°F

Inactive Ingredients

water, glycerin, pentylene glycol, carbomer, silica, tocopheryl acetate, sodium citrate, sodium hydroxide, sodium metabisulfite, diethylhexyl sodium sulfosuccinate, phenoxyethanol, epilobium angustifolium flower/leaf/stem extract, propanediol, acrylates/C10-30 alkyl acrylate
crosspolymer, disodium EDTA, potassium hydroxide

Questions Or Comments?

1-888-LRP LABO 1-888-577-5226
Monday -Friday (9 a.m .- 5p.m. EST)

* Please review the disclaimer below.