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Effaclar
Adapalene · Gel
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Adapalene | 1 mg/g | 829539 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Retinoid [EPC] | EPC | All 35 members |
| Retinoids [CS] | CS | All 35 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 091314-001 | ADAPALENE | GEL | ADAPALENE | Over-the-counter | — | ||
| 091314-002 | ADAPALENE | GEL | ADAPALENE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 5 | Labeling | Approved | July 9, 2019 | Standard |
| Original application | 1 | Approved | July 1, 2010 | — |
Review documents
- 0 · Original application · January 7, 2021
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251223). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse • for the treatment of acne
Purpose
openFDA Drug LabelingPurpose Acne treatment
Dosage and Administration
openFDA Drug LabelingDirections Adults and children 12 years of age and older: • use once daily • clean the skin gently and pat dry before applying the product • cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. • do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age : ask a doctor
Warnings
openFDA Drug LabelingWarnings 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 breast-feeding , 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: • in the first few weeks of use • if using more than one topical acne medication at a time • 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
Active Ingredient
openFDA Drug LabelingActive ingredient Adapalene USP, 0.1% (retinoid)* *read consumer information leaflet
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ADAPALENE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 49967-591-01 | 49967-591 | LOreal USA Products Inc | 1 TUBE in 1 CARTON (49967-591-01) / 45 g in 1 TUBE | August 23, 2019 |
| 49967-591-02 | 49967-591 | LOreal USA Products Inc | 1 TUBE in 1 CARTON (49967-591-02) / 3 g in 1 TUBE | October 22, 2019 |
| 49967-592-01 | 49967-592 | LOreal USA Products Inc | 1 TUBE in 1 CARTON (49967-592-01) / 45 g in 1 TUBE | September 16, 2024 |
| 49967-592-02 | 49967-592 | LOreal USA Products Inc | 1 TUBE in 1 CARTON (49967-592-02) / 3 g in 1 TUBE | September 16, 2024 |
| 49967-591 | 49967-591 | LOreal USA Products Inc | — | August 23, 2019 |
| 49967-592 | 49967-592 | LOreal USA Products Inc | — | September 16, 2024 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.