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TOPCARE MEDICATED DANDRUFF by TOPCO ASSOCIATES LLC

Medically reviewed on Nov 20, 2017

Dosage form: liquid
Ingredients: SELENIUM SULFIDE 10mg in 1mL
Labeler: TOPCO ASSOCIATES LLC
NDC Code: 36800-719

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

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF/ANTI-SEBORRHEIC DERMATITIS

USES

FOR THE RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH DANDRUFF AND SEBORRHEIC DERMATITIS AND TO HELP PREVENT THE CHANCE OF RECURRENCE

WARNINGS

FOR EXTERNAL USE ONLY

ASK A DOCTOR BEFORE USE IF YOU HAVE

SEBORRHEIC DERMATITIS IN AREAS OTHER THAN THE SCALP

WHEN USING THIS PRODUCT

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYE 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

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

SHAKE WELL, APPLY SHAMPOO AND RINSE THOROUGHLY. FOR BEST RESULTS, USE AT LEAST TWICE A WEEK OR AS DIRECTED BY A DOCTOR

OTHER INFORMATION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

WATER (AQUA), SODIUM LAURETH SULFATE, TEA-LAURYL SULFATE, COCAMIDOPROPYL BETAIN, ACRYLATES COPOLYMER, CITRIC ACID, FRAGRANCE (PARFUM), AMMONIUM CHLORIDE, DMDM HYDANTOIN, MENTHOL, SODIUM HYDROXIDE, MAGNESIUM ALUMINUM SILICATE, HYDROXYPROPYL METHYLCELLULOSE, BLUE 1 (CI 42090), RED 33 (CI 17200)

LABEL COPY

TOPCARE  MEDICATED DANDRUFF
selenium sulfide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-719
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (SELENIUM SULFIDE) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
TEA-LAURYL SULFATE 
COCAMIDOPROPYL BETAINE 
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) 
CITRIC ACID MONOHYDRATE 
AMMONIUM CHLORIDE 
DMDM HYDANTOIN 
MENTHOL 
SODIUM HYDROXIDE 
MAGNESIUM ALUMINUM SILICATE 
HYPROMELLOSES 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
1NDC:36800-719-11325 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/17/2014
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture(36800-719)

 
TOPCO ASSOCIATES LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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