SELENIUM SULFIDE- selenium sulfide shampoo 
Sonar Products, 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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Selenium Sulfide 1% Moisturizing Dandruff Shampoo

Drug Facts

Active Ingredient

Selenium sulfide 1%

Purpose

Antidandruff

Use

for relief of flaking and itching due to dandruff and seborrheic dermatitis and to help prevent their 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 eyes thoroughly with water.
  • for 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

Inactive Ingredients

water, ammonium lauryl sulfate, ammonium laureth sulfate, dihydrogenated tallow phthalic acid amide, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, titanium dioxide, hydroxypropyl methylcellulose, sodium isostearyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, FD&C blue no.1 (245-067)

Manufactured By:
Sonar Products, Inc.
609 Industrial Road
Carlstadt, NJ 07072

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

NDC 65255-409-88

SONAR PRODUCTS, INC.

SELENIUM
SULFIDE
1% SHAMPOO

Moisturizing Dandruff
Shampoo

11 Fl. Oz. (325 mL)

Principal Display Panel - 325 mL Bottle Label
SELENIUM SULFIDE 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65255-409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B) SELENIUM SULFIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorTURQUOISEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65255-409-03325 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H02/08/2012
Labeler - Sonar Products, Inc (104283945)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products, Inc104283945MANUFACTURE(65255-409) , LABEL(65255-409)

Revised: 1/2012
Document Id: 2c7fc54b-3301-4c97-a2fa-3e20f5360b21
Set id: e4ab2402-fbf0-4ad3-9a52-d277d2d7f42d
Version: 1
Effective Time: 20120131
 
Sonar Products, Inc