OTC Medication Information: La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT- salicylic acid liquid
L’Oreal USA Products Inc

Active ingredient

Salicylic acid 1.5%

Purpose

Acne treatment

Uses

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

Warnings

For external use only

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
  • children under 12 years of age: ask a doctor

Inactive ingredients

water, alcohol denat., propanediol, glycolic acid, niacinamide, dimethyl isosorbide, pentylene glycol, sodium hydroxide, capitolize-26-buteth-26, PPG-26-buteth-26, hydroxyethylpiperazine ethane sulfonic acid, citric acid, PEG-30 glyceryl cocoate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, capryloyl salicylic acid, biosaccharide gum-1, maltodextrin, phytic acid, polyquaternium-10, fragrance

Questions or comments?

1-888-LRP LABO

1-888-577-5226

Monday — Friday (9 a.m. — 5 p.m. EST)

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LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT
salicylic acid liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-529
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
PROPANEDIOL
GLYCOLIC ACID
NIACINAMIDE
DIMETHYL ISOSORBIDE
PENTYLENE GLYCOL
SODIUM HYDROXIDE
PPG-26-BUTETH-26
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID
CITRIC ACID MONOHYDRATE
PEG-30 GLYCERYL COCOATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
PEG-60 HYDROGENATED CASTOR OIL
CAPRYLOYL SALICYLIC ACID
BIOSACCHARIDE GUM-1
MALTODEXTRIN
FYTIC ACID
POLYQUATERNIUM-10 (10000 MPA.S AT 2%)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-529-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 30 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (49967-529-01)
2 NDC:49967-529-02 1 TUBE in 1 CARTON contains a TUBE
2 3 mL in 1 TUBE This package is contained within the CARTON (49967-529-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M006 05/01/2022
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
COSMETIQUE ACTIVE PRODUCTION 282658798 manufacture (49967-529), pack (49967-529)
Establishment
Name Address ID/FEI Operations
Interspray 364829903 pack (49967-529)

Revised: 12/2023 L’Oreal USA Products Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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