Effaclar

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Effaclar
Generic name
ADAPALENE
Manufacturer
LOreal USA Products Inc
Product type
HUMAN OTC DRUG
SPL set ID
e94854c5-6bb8-43db-b898-4d47a419d075
SPL ID
e94854c5-6bb8-43db-b898-4d47a419d075
Version
1
Effective date
2025-12-23
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:18:04
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use • on damaged skin (cuts, abrasions, eczema, sunburn) • if you are allergic to adapalene or any of the ingredients in this product. If pregnant or breastfeeding , ask a doctor before use. When using this product • limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors • do not wax to remove hair in areas where the product has been applied • during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe • irritation (redness, itching, dryness, burning) is more likely to occur: o in the first few weeks of use o if using more than one topical acne medication at a time o but irritation usually lessens with continued use of this product • it may take up to 3 months of once daily use to see results • avoid product contact with eyes, lips, and mouth. If contact occurs, immediately flush the area with water. • wash hands after use Stop use and ask doctor if • you become pregnant, or are planning to become pregnant, while using the product • you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) • irritation becomes severe • you see no improvement after 3 months of once daily use

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.