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TopCare MEDICATED DANDRUFF by Topco Associates LLC

Medically reviewed on September 29, 2017

Dosage form: shampoo
Ingredients: SELENIUM SULFIDE 1mL in 100mL
Labeler: Topco Associates LLC
NDC Code: 36800-610

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.

Drug Facts Box - Back Label

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 INGREDIENTSWATER, 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

TOPCARE  MEDICATED DANDRUFF
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-610
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (SELENIUM ) SELENIUM SULFIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
TROLAMINE LAURYL SULFATE 
AMMONIUM LAURETH-5 SULFATE 
COCAMIDOPROPYL BETAINE 
MAGNESIUM ALUMINUM SILICATE 
MENTHOL 
COCO DIETHANOLAMIDE 
DMDM HYDANTOIN 
CITRIC ACID MONOHYDRATE 
HYDROXYPROPYL CELLULOSE 
SODIUM CHLORIDE 
SODIUM CITRATE 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:36800-610-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H09/29/2010
Labeler - Topco Associates LLC (006935977)

Document Id: d3eb067c-e627-4368-86c4-3390047d5bfa
Set id: 7333f325-5d46-4a1d-a50b-aef26a37a2a6
Version: 1
Effective Time: 20100929
 
Topco Associates LLC

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