FDA.reportPublic FDA data

PanOxyl

Manufacturer
CROWN LABORATORIES | Sun Pharma Canada Inc.
Effective date
2025-08-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:51

Label at a glance#

ProductPanOxyl
Active ingredientADAPALENE
Label structure11 sections

Dosage and administration

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...

Storage and handling

TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE. store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. protect from freezing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene USP, 0.1% (retinoid) 1

1 read consumer information leaflet

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged skin (cuts, abrasions, eczema, sunburn)
  • if you are allergic to adapalene or any of the ingredients in this product.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type C, edetate disodium, phenoxyethanol, poloxamer 182, propylene glycol, purified water, sodium hydroxide.

Questions?

OTC - QUESTIONS SECTION

1-833-279-6522

SPL UNCLASSIFIED SECTION

Distributed by:
Crown Laboratories, Inc.
Johnson City, TN 37604

P12165.02 panoxyl.com

Made in Canada

PRINCIPAL DISPLAY PANEL - 15 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307731adapalene 0.1 % Topical GelPSN1
307731adapalene 0.001 MG/MG Topical GelSCD1
307731adapalene 0.1 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADAPALENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0284-15PanOxyl15 g in 1 TUBEGEL151
0316-0284-15PanOxyl1 in 1 CARTONGEL11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0284-15GM - Gram0316-02841c11b483-1c32-49c9-bf5d-0d030425ada612026-04-20

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02840316-0284-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLOXAMER 182JX0HIX6OAGIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
ADAPALENE1L4806J2QFACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215940-001ADAPALENEADAPALENE0.1%GEL / TOPICAL2022-01-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1484e616aacf4f…
2026-08-18 06:07:402026-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215940-001ADAPALENE0.1%GEL / TOPICAL2022-01-14a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PanOxylADAPALENECROWN LABORATORIES3bdcb3d7-164e-e678-e063-6394a90a3d6b2025-08-08WarningsExact identifier
ndc (package): 0316-0284-15
ndc (product): 0316-0284
ndc11 (package): 00316028415
spl id: 3bdcb3d7-164d-e678-e063-6394a90a3d6b
spl set id: 3bdcb3d7-164e-e678-e063-6394a90a3d6b

Reported adverse events (FAERS/openFDA)#

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