FDA.reportPublic FDA data

PanOxyl

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:33:41

Label at a glance#

ProductPanOxyl
Active ingredientBENZOYL PEROXIDE
Label structure9 sections

Dosage and administration

clean the skin thoroughly before applying this product work into a lather cover the entire affected area with a thin layer and rinse thoroughly one to three times daily rinse thoroughly and pat dry 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 ...

Storage and handling

Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
  • 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
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation becomes severe

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the skin thoroughly before applying this product
  • work into a lather
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
  • rinse thoroughly and pat dry
  • 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

STORAGE AND HANDLING SECTION

  • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate
Diacetate

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Panoxyl Acne Treatmet Bar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl ®

Acne Treatment Bar

for Face & Body

10% BENZOYL PEROXIDE

MAXIMUM STRENGTH

Clears existing acne and helps prevent new breakouts

Maximum strength without a prescription

No. 1 DERMATOLOGIST RECOMMENDED BENZOYL PEROXIDE BRAND

Net wt. 4 oz (113 g)

10pct bar10pct bar

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303160264047GTIN-13: 0303160264047
EAN-13: 0303160264047
GTIN-12: 303160264047
UPC-A: 303160264047
GTIN storage (14 digits): 00303160264047		P11935.03 10pct bar.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0264-01PanOxyl43 g in 1 CARTONSOAP436
0316-0264-04PanOxyl113 g in 1 CARTONSOAP1136

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0264-04EA - Each0316-0264008f0a48-0869-4d6c-b41b-4a3637868dbc12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02640316-0264-04, 0316-0264-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ICODEXTRIN2NX48Z0A9GIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-11-12monthly-update2026-06-03 17:38:07
42024-07-12full-release2026-06-01 00:15:13

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
PanOxylBENZOYL PEROXIDECrown Laboratoriesff09cbab-304b-4da9-e053-6394a90ae6002026-01-12WarningsExact identifier
ndc (package): 0316-0264-01
ndc (package): 0316-0264-04
ndc (product): 0316-0264
ndc11 (package): 00316026404
ndc11 (package): 00316026401
spl id: 48342795-9bf2-4541-e063-6394a90a10be
spl set id: ff09cbab-304b-4da9-e053-6394a90ae600

Reported adverse events (FAERS/openFDA)#

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