FDA.reportPublic FDA data

PanOxyl

Manufacturer
Crown Laboratories
Effective date
2026-01-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:34:27

Label at a glance#

ProductPanOxyl
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

wet face and work product into a lather cover the entire affected area with a thin layer 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

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

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

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.

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 face and work product into a lather
  • cover the entire affected area with a thin layer 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

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, Butyrospermum Parkii (Shea Butter), Cocamidopropyl Hydroxysultaine, Galactoarabinan, Glycerin, Mandelic Acid, Sodium Chloride, Sodium Cocoate*, Sodium Gluconate, Sodium Palm Kernelate*, Sodium Palmate, Tetrasodium EDTA, Tetrasodium Glutamate Diacetate, Titanium Dioxide (CI 77891), Zinc PCA *contains one or more of these ingredients

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Panoxyl Acne Treatmet Bar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl

Acne Cleansing Bar

for Face & Body

2% SALICYLIC ACID

ACNE TREATMENT BAR

DAILY CONTROL

Clears and helps prevent acne

Gentle, hypoallergenic formula

Helps exfoliate for a clearer complexion

DERMATOLOGIST RECOMMENDED

Net wt. 4 oz (113 g)

Distributed by: Crown Laboratories, Inc.

Johnson City, TN 37604

panoxyl.com

P12961.00

SA Bar CartonSA Bar Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312882salicylic acid 2 % Medicated Bar SoapPSN1
312882salicylic acid 0.02 MG/MG Medicated Bar SoapSCD1
312882salicylic acid 2 % Medicated Bar SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0288-01PanOxyl113 g in 1 CARTONSOAP1131

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02880316-0288-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GALACTOARABINANSL4SX1O487IACT
TETRASODIUM EDTAMP1J8420LUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
SODIUM GLUCONATER6Q3791S76IACT
ZINC PCAC32PQ86DH4IACT
GLYCERINPDC6A3C0OXIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
MANDELIC ACIDNH496X0UJXIACT
SODIUM COCOATER1TQH25F4IIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
SODIUM PALMATES0A6004K3ZIACT

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
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
ndc (package): 0316-0288-01
ndc (product): 0316-0288
ndc11 (package): 00316028801
spl id: 48fd0116-d7c4-7f6d-e063-6394a90a0f7b
spl set id: 48fd0106-4db4-f33a-e063-6294a90a5a0b

Reported adverse events (FAERS/openFDA)#

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