FDA.reportPublic FDA data

PanOxyl

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
26
Source
full-release
Hydrated at
2026-06-01 01:32:38

Label at a glance#

ProductPanOxyl
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

wet area to be cleansed apply acne wash and gently massage area for 1-2 minutes rinse thoroughly and pat dry because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 p...

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 4%

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 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
  • 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.

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

  • wet area to be cleansed
  • apply acne wash and gently massage area for 1-2 minutes
  • rinse thoroughly and pat dry
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 (4%)

INACTIVE INGREDIENT SECTION

Aqua, Carbomer, Decyl Glucoside, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Glycerin, Oleic Acid, Palmitic Acid, PEG-40 Stearate, Polyacrylate Crosspolymer-6, Propanediol, Silica, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Stearate, Sorbitol, Stearic Acid, t-Butyl alcohol, Xanthan Gum

Questions or comments?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Panoxyl 4% Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl®

ACNE CREAMY WASH

for Face & Body

4% Benzoyl Peroxide

Acne Treatment Wash

Daily Control

Clears existing acne and helps prevent new breakouts

Net wt. 6oz (170g)

PanOxyl 4% TubePanOxyl 4% Tube

Panoxyl 4% Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl®

ACNE CREAMY WASH

for Face & Body

4% Benzoyl Peroxide

Acne Treatment

Daily Control

Clears existing acne and helps prevent new breakouts

Formulated to be genlt on skin

Net wt. 6oz (170g)

6oz carton6oz carton

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-02-13C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0227-062023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash
0316-0228-552023-01-30C16284748780-1f386c649-f347-0266-e053-dadaa90a7c1aPanoxyl Acne Creamy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0227-06PanOxyl170 g in 1 TUBECREAM17026
0316-0227-06PanOxyl1 in 1 CARTONCREAM126
0316-0227-10PanOxyl1 in 1 CARTONCREAM126
0316-0227-10PanOxyl85 g in 1 TUBECREAM8526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0227-06GM - Gram0316-0227a24cf241-a250-4e93-b697-1ac6387089ad12019-01-24

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02270316-0227-06, 0316-0227-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DIMETHICONE92RU3N3Y1OIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
PALMITIC ACID2V16EO95H1IACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM CHLORIDE451W47IQ8XIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
STEARIC ACID4ELV7Z65APIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
POLYOXYL 40 STEARATE13A4J4NH9IIACT
PROPANEDIOL5965N8W85TIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
252025-11-12monthly-update2026-06-03 17:38:24
232024-07-16full-release2026-06-01 00:15:22

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 Laboratories7b301b94-3cc8-b05b-e053-2991aa0aa5612026-01-12WarningsExact identifier
ndc (package): 0316-0227-06
ndc (package): 0316-0227-10
ndc (product): 0316-0227
ndc11 (package): 00316022706
ndc11 (package): 00316022710
spl id: 48343359-a966-5327-e063-6294a90a54e5
spl set id: 7b301b94-3cc8-b05b-e053-2991aa0aa561

Reported adverse events (FAERS/openFDA)#

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