Label: TARSUM PROFESSIONAL- coal tar shampoo
- NDC Code(s): 11086-011-01, 11086-011-02, 11086-011-11
- Packager: Summers Laboratories Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 11, 2017
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
2% COAL TAR
(10% LCD EQUIV. TO 2% COAL TAR)Close
PSORIASIS, SEBORRHEIC DERMATITIS, DANDRUFF TREATMENTClose
- INDICATIONS & USAGE
- CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF
FOR EXTERNAL USE ONLYClose
- 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 or genitals
- 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 up to 24 hours after application.
- do not use for prolonged periods without consulting a doctor.
- do not use this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor.
- STOP USE
Stop 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 CONTCT A POISON CONTROL CENTER RIGHT AWAY.Close
- OTHER SAFETY INFORMATION
In rare instances, temporary discoloration of gray or blonde hair may occur.Close
- DOSAGE & ADMINISTRATION
- For use as a scalp treatment before showering: Twist open applicator tip. Apply evenly to affected areas. Leave on for 5 minutes, gradually increasing treatment time to 1 hour, or as directed by your doctor. Rinse thoroughly.
- As a shampoo: Wet hair, apply Tarsum for several minutes, then rinse.
- For best results use twice a week or as directed by a physician.
- INACTIVE INGREDIENT
water, TEA lauryl sulfate, cocamide DEA, sodium lauryl sulfate, ethanol (8%), salicylic acid, triethanolamine, glycerin, lauryl alcohol, diethanolamine, sodium chloride, polysorbate 80, fragranceClose
- OTHER SAFETY INFORMATION
Store at controlled room temperature
59° to 86° F (15° to 30° C)Close
Questions or comments?
Call 1-800-533-7546 (USA and Canada)
For more information go to www.sumlab.comClose
- INGREDIENTS AND APPEARANCE
coal tar shampoo
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11086-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA) COCO DIETHANOLAMIDE (UNII: 92005F972D) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ALCOHOL (UNII: 3K9958V90M) 8 g in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) LAURYL ALCOHOL (UNII: 178A96NLP2) DIETHANOLAMINE (UNII: AZE05TDV2V) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11086-011-11 1 in 1 BOX 10/30/2013 1 NDC:11086-011-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:11086-011-02 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/30/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 10/30/2013 Labeler - Summers Laboratories Inc (002382612) Establishment Name Address ID/FEI Business Operations Summers Laboratories Inc 002382612 manufacture(11086-011) , pack(11086-011)