FDA.reportPublic FDA data

PanOxyl Acne Clearing Spot Treatment

Manufacturer
Crown Laboratories
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-03 18:04:09

Label at a glance#

ProductPanOxyl Acne Clearing Spot Treatment
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily 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 ...

Storage and handling

store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not exceed 30°C (86°F).

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 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

  • irritaiton becomes severe

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare 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
  • cover the entire affected area with a thin layer one to three times daily
  • 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 a 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°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Do not exceed 30°C (86°F).

Inactive ingedients

INACTIVE INGREDIENT SECTION


1,2-Hexanediol, 4-t-Butylcyclohexanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Bisabolol, Butyrospermum Parkii (Shea) Butter, Carbomer, Carbomer Homopolymer Type C, Citric Acid, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexylene Glycol, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Isostearyl Alcohol, Niacinamide, PEG-40 Stearate, Pentylene Glycol, Propanediol, Silica, Sodium Citrate, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Stearate, Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

PanOxyl Acne Clearing Spot Treatment 1oz Tube PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl

Acne Clearing Spot Treatment

for Face

10% BENZOYL PEROXIDE ACNE TREATMENT GEL

MAXIMUM STRENGTH

Clears existing ance and helps prevent new breakouts

DERMATOLOGIST RECOMMNENDED

Net wt. 1 oz (28 g)

Distributed by Crown Laboratories, Inc. Johnson City, TN

P12714.00

1oz tube1oz tube

PanOxyl Acne Clearing Spot Treatment 1oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl

Acne Clearing Spot Treatment

for Face

10% BENZOYL PEROXIDE ACNE TREATMENT GEL

MAXIMUM STRENGTH

Clears existing ance and helps prevent new breakouts

Powerful, fast-acting maximum strength formula

No. 1 DERMATOLOGIST RECOMMNENDED BENZOYL PEROXIDE BRAND

Net wt. 1 oz (28 g)

Distributed by Crown Laboratories, Inc. Johnson City, TN

P12715.01

1oz carton1oz carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
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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

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02980316-0298-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
DIETHYLHEXYL SODIUM SULFOSUCCINATEF05Q2T2JA0IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
PENTYLENE GLYCOL50C1307PZGIACT
CITRIC ACID2968PHW8QPIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
XANTHAN GUMTTV12P4NEEIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
PEG-40 STEARATEECU18C66Q7IACT
HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE9CO8OUL4THIACT
SODIUM CITRATE1Q73Q2JULRIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
4-T-BUTYLCYCLOHEXANOLK0H1405S9CIACT
NIACINAMIDE25X51I8RD4IACT
EDETATE DISODIUM7FLD91C86KIACT
SORBITAN STEARATENVZ4I0H58XIACT
SODIUM HYDROXIDE55X04QC32IIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
BISABOLOL24WE03BX2TIACT
CARBOMER0A5MM307FCIACT
SILICAETJ7Z6XBU4IACT
SODIUM HYALURONATEYSE9PPT4THIACT

Source Document#

Source XML

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
PanOxyl Acne Clearing Spot TreatmentBENZOYL PEROXIDECrown Laboratories507150a0-9c20-4a2e-e063-6394a90ab9c72026-04-27WarningsExact identifier
ndc (package): 0316-0298-01
ndc (product): 0316-0298
ndc11 (package): 00316029801
spl id: 50715555-1b9b-2217-e063-6394a90ac318
spl set id: 507150a0-9c20-4a2e-e063-6394a90ab9c7

Reported adverse events (FAERS/openFDA)#

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