Label: LA ROCHE POSAY EFFACLAR DERMATOLOGICAL ACNE SYSTEM 3 STEP ACNE ROUTINE- benzoyl peroxide and salicylic acid kit

  • NDC Code(s): 49967-282-01
  • Packager: L'Oreal USA Products Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 21, 2024

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  • Effaclar Medicated Gel Cleanser

    Drug Facts

  • Active ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    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.
  • Keep out of reach of children.

    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
  • 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

  • Questions or comments?

    1-888-577-5226

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

  • Effaclar Clarifying Solution

    Drug Facts

  • Active ingredient

    Salicylic acid 0.5%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • 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

    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.

  • Inactive Ingredients

    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?

    1-888-577-5626

  • Effaclar Duo Dual Action Acne Treatment

    Drug Facts

  • Active ingredient

    Benzoyl peroxide 5.5%

  • Purpose

    Acne medication

  • Uses

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

    • 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.
  • Other information

    store at 20° - 25°C (68° - 77°F)

  • 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

  • Questions or comments?

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

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

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • INGREDIENTS AND APPEARANCE
    LA ROCHE POSAY EFFACLAR DERMATOLOGICAL ACNE SYSTEM 3 STEP ACNE ROUTINE 
    benzoyl peroxide and salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-282
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-282-011 in 1 CARTON01/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 100 mL
    Part 21 BOTTLE 100 mL
    Part 31 TUBE 20 mL
    Part 1 of 3
    LA ROCHE POSAY EFFACLAR MEDICATED GEL CLEANSER 
    salicylic acid gel
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POLYQUATERNIUM-47 (METHACRYLAMIDOPROPYLTRIMETHYLAMMONIUM CHLORIDE-CO-METHYL ACRYLATE-CO-ACRYLIC ACID 46:8:46; 1300000 MW) (UNII: G938900MID)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM006
    Part 2 of 3
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR CLARIFYING 
    salicylic acid solution
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    MENTHOL (UNII: L7T10EIP3A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM006
    Part 3 of 3
    LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE55 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SILICA (UNII: ETJ7Z6XBU4)  
    CARBOMER (UNII: 0A5MM307FC)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT (UNII: 08H094218D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/01/2015
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458MANUFACTURE(49967-282)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beauty Manufacturing Solutions Corp.783200723manufacture(49967-282)