Keralyt
FDA Label NDC 11086-038

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summers Laboratories Inc for the product Keralyt (NDC 11086-038). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT

SALICYLIC ACID 3%

Otc - Purpose

PURPOSE

PSORIASIS, SEBORRHEIC DERMATITIS

Indications & Usage

USES

HELPS STOP THESE SYMPTOMS OF PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF

  • FLAKING
  • SCALING
  • REDNESS
  • IRRITATION
  • ITCHING

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Ask Doctor

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

Otc - When Using

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

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

Otc - Keep Out Of Reach Of Children

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

DIRECTIONS

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

Inactive Ingredient

INACTIVE INGREDIENTS

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

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