FDA.reportPublic FDA data

PanOxyl Clarifying Exfoliant

Manufacturer
Crown Laboratories, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:32:51

Label at a glance#

ProductPanOxyl Clarifying Exfoliant
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

shake well before using 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

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

  • shake well before using
  • 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

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

Betaine, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Hydroxyacetophenone, Pentylene Glycol, Phenoxyethanol, Potassium Sorbate, Propanediol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sorbic Acid, Spirulina Platensis (Blue Algae) Extract

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Panoxyl Clarifying Exfoliant Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanOxyl®

Clarifying Exfoliant

for Acne Prone Skin

2% SALICYLIC ACID

ACNE TREATMENT SOLUTION

Clears and helps prevent acne

Unclogs and minimizes the appearance of pores

Gentle leave-on formula

Blue Algae and Antioxidants help calm irritation and redness

DERMATOLOGIST RECOMMENDED

4 fl oz (118 mL)

P12117.02

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251577salicylic acid 2 % Topical SolutionPSN5
251577salicylic acid 20 MG/ML Topical SolutionSCD5
251577salicylic acid 2 % Topical SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0296-04PanOxyl Clarifying Exfoliant118 mL in 1 BOTTLELIQUID1185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0296-04ML - Milliliter0316-02961c225031-5797-4de6-b726-3a9d4d1afd5312025-05-14

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02960316-0296-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETAINE3SCV180C9WIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MATRICARIA CHAMOMILLA FLOWERING TOP3VNC7T6Z02IACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
SALICYLIC ACIDO414PZ4LPZACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
SPIRULINA PLATENSIS9L3TIH1UUEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-11-12monthly-update2026-06-03 17:39:06
32024-11-26full-release2026-06-01 00:39:32

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 Clarifying ExfoliantSALICYLIC ACIDCrown Laboratories, Inc.faa6576c-2af2-d86b-e053-6294a90ada2d2026-01-12WarningsExact identifier
ndc (package): 0316-0296-04
ndc (product): 0316-0296
ndc11 (package): 00316029604
spl id: 48342be5-a7f3-4e66-e063-6394a90ae376
spl set id: faa6576c-2af2-d86b-e053-6294a90ada2d

Reported adverse events (FAERS/openFDA)#

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