MedPath

La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment

Drug Facts

Approved
Approval ID

bc9fffbc-c176-4d89-b1c6-294a8439a930

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 15, 2025

Manufacturers
FDA

COSMETIQUE ACTIVE PRODUCTION

DUNS: 282658798

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Salicylic acid

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69625-926
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic acid
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 15, 2025
FDA Product Classification

INGREDIENTS (34)

SALICYLIC ACIDActive
Quantity: 5 mg in 1 mL
Code: O414PZ4LPZ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
ISOCETYL STEARATEInactive
Code: 3RJ7186O9W
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
ISOPROPYL LAUROYL SARCOSINATEInactive
Code: LYR06W430J
Classification: IACT
POTASSIUM CETYL PHOSPHATEInactive
Code: 03KCY6P7UT
Classification: IACT
SORBITAN OLEATEInactive
Code: 06XEA2VD56
Classification: IACT
ZINC PCAInactive
Code: C32PQ86DH4
Classification: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785I
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MYRISTYL MYRISTATEInactive
Code: 4042ZC00DY
Classification: IACT
2-OLEAMIDO-1,3-OCTADECANEDIOLInactive
Code: 30D478BUNR
Classification: IACT
MANNOSEInactive
Code: PHA4727WTP
Classification: IACT
POLOXAMER 338Inactive
Code: F75JV2T505
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
HYDROXYETHOXYPHENYL BUTANONEInactive
Code: TH7XI54W45
Classification: IACT
CAPRYLOYL SALICYLIC ACIDInactive
Code: 5F7PJF6AA4
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
VITREOSCILLA LYSATEInactive
Code: 68DV8T89Y2
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEInactive
Code: YA22H34H9Q
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
PENTYLENE GLYCOLInactive
Code: 50C1307PZG
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%)Inactive
Code: 5F4963KLHS
Classification: IACT
PIROCTONE OLAMINEInactive
Code: A4V5C6R9FB
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEInactive
Code: F01RIY4371
Classification: IACT
ORYZA SATIVA (RICE) STARCHInactive
Code: 4DGK8B7I3S
Classification: IACT
POMEGRANATE FRUIT RINDInactive
Code: RS999V57DU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/15/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/15/2025

Uses

  • clears acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/15/2025

Active ingredient

Salicylic acid 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/15/2025

Purpose

Acne treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/15/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/15/2025

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/15/2025

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/15/2025

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
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/15/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/15/2025

Questions or comments?

1-888-LRP LABO

1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.