SAFEWAY MEDICATED DANDRUFF- selenium sulfide shampoo 
SAFEWAY 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 RECURRENCE.

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 EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER. FOR USE ON COLOR TREATED OR PERMED HAIR, RINSE THOROUGHLY.

STOP USING THIS PRODUCT AND ASK A DOCTOR IF

CONDITION WORSENS O 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.

INACTIVE INGREDIENTS

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

QUESTIONS OR COMMENTS?

1-888-723-3929

LABEL COPY

IMAGE OF THE LABEL

SAFEWAY  MEDICATED DANDRUFF
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-617
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
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)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-617-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H06/04/2012
Labeler - SAFEWAY INC. (009137209)
Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
Establishment
NameAddressID/FEIBusiness Operations
APOLLO HEALTH AND BEAUTY CARE201901209manufacture

Revised: 6/2012
Document Id: 57d116c0-0b01-474e-981c-da18b868d0a4
Set id: cb82bdc9-4505-4f07-934c-030ee371d5aa
Version: 1
Effective Time: 20120605
 
SAFEWAY INC.