FDA.reportPublic FDA data

SUMMERS LABS (as PLD) - KERALYT GEL 3% SALICYLIC ACID (11086-038)

Manufacturer
Summers Laboratories Inc
Effective date
2026-10-14
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-20 03:03:46

Label at a glance#

ProductKeralyt 3 PERCENT
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

SALICYLIC ACID 3%

OTC - PURPOSE SECTION

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS

INDICATIONS & USAGE SECTION

USES

HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

  • FLAKING
  • SCALING
  • REDNESS
  • IRRITATION
  • ITCHING

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - ASK DOCTOR SECTION

ASK A DOCTOR BEFORE USE IF CONDITION COVERS A LARGE AREA OF THE BODY

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

  • DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF IRRITATION PERSISTS, CONSULT A DOCTOR.

OTC - STOP USE SECTION

STOP USE AND CONSULT A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

OTHER SAFETY INFORMATION

FLAMMABLE

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • APPLY TO AFFECTED AREA ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

PROPYLENE GLYCOL, SD-40 ALCOHOL (21%), WATER, HYDROXYPROPYLCELLULOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Keralyt 3-SA_Unit CartonKeralyt 3-SA_Unit Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11086-038-012025-01-30C16284748780-12cef2736-a736-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - KERALYT GEL 3% SALICYLIC ACID (11086-038)
11086-038-012025-01-30C16284748780-12cef2736-a736-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - KERALYT GEL 3% SALICYLIC ACID (11086-038)

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11086-038-01GM - Gram11086-03823391bc7-c690-45f0-b460-e9dd0db0b38c12017-10-13

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11086-03811086-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
HYDROXYPROPYL CELLULOSERFW2ET671PIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72023-10-09full-release2026-05-31 23:56:33

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
074d1247-a817-29b6-e063-6294a90aa64ec02018de-3b03-49b7-9152-c65b248345ad2023-10-09WarningsExact identifier
spl set id: c02018de-3b03-49b7-9152-c65b248345ad

Reported adverse events (FAERS/openFDA)#

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