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MEDICATED DANDRUFF by AMERICAN SALES COMPANY

Medically reviewed on August 21, 2017

Dosage form: shampoo
Ingredients: SELENIUM SULFIDE 1mL in 100mL
Labeler: AMERICAN SALES COMPANY
NDC Code: 41520-614

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

USES

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

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.

DIRECTIONS

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

QUESTIONS/COMMENTS?

1-866-690-3030

INACTIVE INGREDIENTS

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

Front and Back labels

MEDICATED DANDRUFF 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-614
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 
COCAMIDOPROPYL BETAINE 
MAGNESIUM ALUMINUM SILICATE 
MENTHOL 
COCO DIETHANOLAMIDE 
DMDM HYDANTOIN 
CITRIC ACID MONOHYDRATE 
HYPROMELLOSES 
FD&C BLUE NO. 1 
D&C RED NO. 33 
SODIUM CITRATE 
SODIUM CHLORIDE 
AMMONIUM LAURETH-2 SULFATE 
Packaging
#Item CodePackage Description
1NDC:41520-614-11325 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/19/2011
Labeler - AMERICAN SALES COMPANY (809183973)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIOperations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

 
AMERICAN SALES COMPANY

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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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