Cutar
FDA Label NDC 11086-105

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 Cutar (NDC 11086-105). 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 - do not use, otc - stop use, 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

7.5% L.C.D. (EQUIVALENT TO 1.5% COAL TAR)

Otc - Purpose

PURPOSE

PSORIASIS, SEBORREIC DERMATITIS TREATMENT

Indications & Usage

USE

  • CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS AND SEBORRHEIC DERMATITIS

Warnings

WARNINGS

FOR EXTERNAL USE ONLY

Otc - Ask Doctor

ASK A DOCTOR BEFORE USE IF YOU HAVE

  • CONDITION THAT COVERS A LARGE AREA OF THE BODY
  • CONDITION IN OR AROUND THE RECTUM, GENITAL AREA OR GROIN

Otc - When Using

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER
  • USE CAUTION IN EXPOSING SKIN TO SUNLIGHT AFTER APPLYING THIS PRODUCT. IT MAY INCREASE YOUR TENDENCY TO SUNBURN FOR UP TO 24 HOURS AFTER APPLICATION

Otc - Do Not Use

DO NOT USE

  • FOR PROLONGED PERIODS WITHOUT CONSULTING A DOCTOR
  • WITH OTHER FORMS OF PSORIASIS THERAPY UNLESS DIRECTED TO DO SO BY A DOCTOR

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF

  • CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE AS DIRECTED
  • EXCESSIVE IRRITATION OCCURS

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

  • IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
  • TO PREVENT STAINING DO NOT USE IN PLASTIC OR FIBERGLASS TUBS, SINKS OR BASINS. CUTAR MAY STAIN LIGHT COLORED FABRICS

Dosage & Administration

DIRECTIONS

  • APPLY TO AFFECTED AREAS ONE TO FOUR TIMES DAILY OR AS DIRECTED BY A DOCTOR
  • AS A MEDICATED LOTION: GENTLY RUB A SMALL AMOUNT ONTO AFFECTED AREAS. BLOT OFF EXCESS WITH A TISSUE TO HELP PREVENT STAINING OF CLOTHING OR LINENS
  • IN THE BATH: POUR A LIBERAL QUANTITY (2 TO 4 OZ.) INTO THE TUB, MAKING SURE CUTAR IS WELL MIXED. SOAK FOR 10 TO 20 MINUTES, OR AS DIRECTED BY YOUR DOCTOR. AFTER TREATMENT, PAT SKIN DRY.
  • GUARD AGAINST SLIPPING.
  • AS A HAND OR FOOT SOAK: ADD 1 TO 2 OZ. TO A SINK OR BASIN. MIX WELL AND SOAK FOR 5 TO 10 MINUTES OR AS DIRECTED BY YOUR DOCTOR.

Inactive Ingredient

INACTIVE INGREDIENTS

WATER, MINERAL OIL, ISOPROPYL MYRISTATE, POLYSORBATE 80, SORBITAN SESQUIOLEATE, LANOLIN ALCOHOLS EXTRACT, METHYL AND PROPYL PARABENS, FRAGRANCE, XANTHAN GUM, CARBOMER

Package Label.Principal Display Panel

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