EQUALINE MOISTURIZING DANDRUFF MEDICATED FORMULA- selenium sulfide shampoo 
Supervalu 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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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 eyes. If contact occurs, rinse with water. For use on color treated or permed hair, rinse thoroughly

Stop using this product and ask 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

Questions? Comments?

1 - 877 - 932 - 7948

Inactive Ingredients

Water (Aqua), Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Dihydrogenated Tallow Phthalic Acid Amide, Cocamide DEA, Fragrance (Parfum), Titanium Dioxide, Dimethicone, Hydroxypropyl Methylcellulose, Citric Acid, Sodium Isostearoyl Lactylate, DMDM Hydantoin, Aloe Barbadensis Leaf Juice, Sodium Citrate, Sodium Chloride, Blue 1 (CI 42090)

Package Front and Back Labels

ra11.jpg
11OZ front and back labels
EQUALINE MOISTURIZING DANDRUFF  MEDICATED FORMULA
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-611
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)  
AMMONIUM LAURETH-2 SULFATE (UNII: 698O4Z48G6)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-611-11325 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H10/15/2010
Labeler - Supervalu Inc (006961411)
Registrant - Apollo Health and Beauty Care (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care201901209manufacture

Revised: 10/2010
Document Id: f80715b8-43c9-4aeb-8d8d-cc5fa1162cd4
Set id: f5b5fee6-2822-4333-8c0d-b96f5d386e18
Version: 1
Effective Time: 20101015
 
Supervalu Inc