TOPCARE MEDICATED DANDRUFF- selenium sulfide shampoo

TopCare by

Drug Labeling and Warnings

TopCare by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

• ANTI DANDRUFF

WARNINGS

• FOR EXTERNAL USE ONLY.
  

ASK A DOCTOR BEFORE USING IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

• AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. FOR USE ON COLOR-TREATED OR PERMED HAIR, RINSE THOROUGHLY.
  

STOP USE AND ASK A DOCTOR IF

• CONDITION WORSENS OR DOES NOT IMPROVE AFTER REGULAR USE OF THIS PRODUCT AS DIRECTED.
  

KEEP OUT OF REACH OF CHILDREN

• IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
  

USE

FOR RELIEF OF FLAKING AND ITCHING DUE TO DANDRUFF, AND SEBORRHEIC DERMATITIS, AND TO HELP PREVENT THE CHANCE OF RE-OCCURRENCE.

DIRECTIONS

• SHAKE WELL, SHAMPOO, THEN RINSE THROUGHLY.
• FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR.
  

INACTIVE INGREDIENTS

WATER, AMMONIUM LAURYL SULFATE, TEA-LAURYL SULFATE, AMMONIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, MAGNESIUM ALUMINUM SILICATE, FRAGRANCE, MENTHOL, COCAMIDE DEA, DMDM HYDANTOIN, CITRIC ACID, HYDROXYPROPYL METHYLCELLULOSE, SODIUM CITRATE, SODIUM CHLORIDE, BLUE 1 (CI 42090), RED 33 (CI 17200)

PACKAGE FRONT AND BACK LABELS

tc11.jpg

INGREDIENTS AND APPEARANCE

TOPCARE  MEDICATED DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B)	SELENIUM SULFIDE	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MENTHOL (UNII: L7T10EIP3A)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-610-11	325 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/29/2010

Labeler - Topco Associates LLC (006935977)