CUTAR by Summers Laboratories Inc CUTAR- coal tar lotion

CUTAR by

Drug Labeling and Warnings

CUTAR by is a Otc medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

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

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

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

STOP USE

STOP USE AND ASK A DOCTOR IF

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CUTAR 
coal tar lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11086-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11086-105-01	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/29/2013
2	NDC: 11086-105-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	10/29/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	10/29/2013

Labeler - Summers Laboratories Inc (002382612)

Establishment
Name	Address	ID/FEI	Business Operations
Summers Laboratories Inc		002382612	manufacture(11086-105)