MEDICATED DANDRUFF  MAXIMUM STRENGTH- selenium sulfide shampoo 
WAL-MART STORES INC

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.

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DRUG FACTS

ACTIVE INGREDIENT

SELENIUM SULFIDE 1%

PURPOSE

ANTI-DANDRUFF

USES

FOR RELIEF OF FLAKING AND ITCHING ASSOCIATED WITH 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 USING THIS PRODUCT 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, 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, 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, RED 33.

QUESTIONS?

CALL: 1-888-287-1915

Front and back labels

image of label
MEDICATED DANDRUFF   MAXIMUM STRENGTH
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1.0000 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-610-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/19/2011
Labeler - WAL-MART STORES INC (051957769)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 8/2011
Document Id: 95e0bc76-6ea1-460c-8e2e-b1549f9feedb
Set id: 4875f90b-7f40-4f0b-9fcf-048aaef0708f
Version: 2
Effective Time: 20110819
 
WAL-MART STORES INC