Active Ingredient
Salicylic acid 1.2%
La Roche Posay Laboratoire Dermatologique Effaclar Az Acne Treatment Cream
FDA Label NDC 69625-735
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 Az Acne Treatment (NDC 69625-735). 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.
Label Section Quick Index
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
- shake well before use
- 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.
Other Information
- store at room temperature 68⁰ – 77⁰F
- protect from freezing
Inactive Ingredients
water, azelaic acid, C15-19 alkane, glycerin, triethyl citrate, diglycerin, panthenol, silica, ammonium polyacryloyldimethyl taurate, taraxacum officinale (dandelion) rhizome/root extract, zinc gluconate, glyceryl stearate, PEG-100 stearate, sodium hyaluronate, sodium hydroxide, sodium phosphate, disodium phosphate, hydroxyethylcellulose, hydroxypropyl starch phosphate, tetrasodium glutamate diacetate, citric acid, trisodium ethylenediamine disuccinate, pentylene glycol, polysorbate 60, fragrance
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