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PanOxyl
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 |
|---|---|---|---|---|---|---|---|
| 215940-001 | ADAPALENE | GEL | ADAPALENE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 1 | Manufacturing (CMC) | Approved | July 6, 2023 | Unknown |
| Original application | 1 | Approved | January 14, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250808). 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 Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
openFDA Drug LabelingDo not use on damaged skin (cuts, abrasions, eczema, sunburn) if you are allergic to adapalene or any of the ingredients in this product.
Stop Use
openFDA Drug LabelingStop 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 |
|---|---|---|---|---|
| 0316-0143-15 | 0316-0143 | CROWN LABORATORIES | 1 TUBE in 1 CARTON (0316-0143-15) / 15 g in 1 TUBE | February 6, 2023 |
| 0316-0284-15 | 0316-0284 | CROWN LABORATORIES | 1 TUBE in 1 CARTON (0316-0284-15) / 15 g in 1 TUBE | August 8, 2025 |
| 0316-0143 | 0316-0143 | CROWN LABORATORIES | — | February 6, 2023 |
| 0316-0284 | 0316-0284 | CROWN LABORATORIES | — | August 8, 2025 |
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.