CUTAR

Manufacturer
Summers Laboratories Inc
Effective date
2023-10-09
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:56:32

Label at a glance#

ProductCUTAR
Active ingredientCOAL TAR
Label structure12 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

PURPOSE

PSORIASIS, SEBORREIC DERMATITIS TREATMENT

INDICATIONS & USAGE SECTION

USE

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

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

CUT6 label 0417CUT6 label 0417

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
427689coal tar 7.5 % Topical EmulsionPSN8
1294106Cutar 7.5 % Topical LotionPSN8
1294106coal tar 75 MG/ML Topical Lotion [Cutar]SBD8
427689coal tar 75 MG/ML Topical LotionSCD8
1294106Cutar 7.5 % Topical LotionSY8
1294106Cutar 75 MG/ML Topical LotionSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11086-105-012025-01-30C16284748780-12cef2736-5f08-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - CUTAR (11086-105)
11086-105-022025-01-30C16284748780-12cef2736-5f08-d83d-e063-dadaa90ab31fSUMMERS LABS (as PLD) - CUTAR (11086-105)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11086-105-01CUTAR180 mL in 1 BOTTLELOTION1808
11086-105-02CUTAR3785 mL in 1 JUGLOTION37858

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11086-105CUTAR (COAL TAR) LOTION [SUMMERS LABORATORIES INC]8Legacy NDC, 2 package rows20231010_5fa7b421-50f7-469c-b3db-62e8579bd299.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11086-105-01ML - Milliliter11086-105d1abf3e5-49e0-46bc-a57f-4c0fa958da8e12022-04-06

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11086-10511086-105-01, 11086-105-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
074d03df-c1b0-1372-e063-6294a90a17ac5fa7b421-50f7-469c-b3db-62e8579bd2992023-10-09WarningsExact identifier
spl id: 074d03df-c1b0-1372-e063-6294a90a17ac
spl set id: 5fa7b421-50f7-469c-b3db-62e8579bd299

Reported adverse events (FAERS/openFDA)#

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