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  5. Label Information: La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine

FDA Label for La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine

View Indications, Usage & Precautions

Table of Contents

    1. EFFACLAR MEDICATED GEL CLEANSER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. EFFACLAR CLARIFYING SOLUTION
    12. OTHER INFORMATION
    13. EFFACLAR DUO DUAL ACTION ACNE TREATMENT
    14. USES
    15. DO NOT USE IF YOU
    16. STOP USE AND ASK A DOCTOR IF
    17. INGREDIENTS
    18. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine Product Label

The following document was submitted to the FDA by the labeler of this product L'oreal Usa Products Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Effaclar Medicated Gel Cleanser



Drug Facts


Active Ingredient



Salicylic acid 2%

Salicylic acid 0.5%

Benzoyl peroxide 5.5%


Purpose



Acne treatment

Acne treatment

Acne medication


Use



for the treatment of acne

for the treatment of acne


Warnings



For external use only

For external use only

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.

    • 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.

    • 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

Keep Out Of Reach Of Children.



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

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

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
    • 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
      • 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.

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

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?



1-888-577-5226

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

1-888-577-5626

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

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


Effaclar Clarifying Solution



Drug Facts


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.

store at 20° - 25°C (68° - 77°F)


Effaclar Duo Dual Action Acne Treatment



Drug Facts


Uses



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

Do Not Use If You



  • have very sensitive skin
  • are sensitive to benzoyl peroxide

Stop Use And Ask A Doctor If



irritation becomes severe


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


Package Label.Principal Display Panel



image of a carton - LRPAcneKitEff

image of a carton - LRPAcneKitEff


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