La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multitarget Acne Treatment Liquid
FDA Label NDC 69625-058

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetique Active Production for the product La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multitarget Acne Treatment (NDC 69625-058). 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, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Salicylic acid 0.5%

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

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.

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 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

Other Information

  • store at room temperature 68°-77°F
  • protect from freezing

Inactive Ingredients

water, glycerin, dimethicone, isocetyl stearate, niacinamide, isopropyl lauroyl sarcosinate, silica, ammonium polyacryloyldimethyl taurate, oryza sativa (rice) starch, punica granatum pericarp extract, potassium cetyl phosphate, sorbitan oleate, zinc PCA, glyceryl stearate SE, isohexadecane, sodium hydroxide, myristyl myristate, 2-oleamido-1,3-octadecanediol, mannose, poloxamer 338, propanediol, hydroxyethoxyphenyl butanone, capryloyl salicylic acid, caprylyl glycol, vitreoscilla ferment, citric acid, trisodium ethylenediamine disuccinate, maltodextrin, xanthan gum, pentylene glycol, polysorbate 80, acrylamide/sodium acryloyldimethyltaurate copolymer, piroctone olamine, fragrance

Questions Or Comments?

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Package Label.Principal Display Panel

3 (3ml)

3 (3ml)

3ml (3x15)

3ml (3x15)

40 mL (40ml)

40 mL (40ml)

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