RUGBY ANTI-DANDRUFF- selenium sulfide shampoo 
Rugby Laboratories, 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.

----------

Rugby® Anti-Dandruff

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff

Use

relieves scalp flaking and itching due to dandruff and seborrheic dermatitis, and helps 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, it is especially important to rinse thoroughly.

Stop use and ask a doctor if condition worsens or does not improve after regular use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store at room temperature

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamidopropyl betaine, cocamide DEA, magnesium aluminum silicate, hypromellose, fragrance, menthol, DMDM hydantoin, citric acid, sodium chloride, FD&C blue no. 1, D&C red no. 33

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm ET,
Monday - Friday

PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

COMPARE TO
ACTIVE INGREDIENT IN
SELSUN BLUE®*

Rugby®
NDC 0536-1995-53

New
Formula

ANTI •
DANDRUFF
SHAMPOO

Selenium Sulfide 1 %

BLUE FORMULA
FOR NORMAL HAIR

Helps to control dandruff symptoms
Leaves hair soft and manageable

05-2675

7 fl oz
(207 mL)

SATISFACTION GUARANTEED
Rugby
• OR YOUR MONEY BACK •

Principal Display Panel - 207 mL Bottle Label
RUGBY ANTI-DANDRUFF 
selenium sulfide shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-1995
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Selenium Sulfide (Selenium Sulfide) Selenium Sulfide10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Ammonium Laureth-2 Sulfate 
Ammonium Lauryl Sulfate 
Cocamidopropyl Betaine 
Coco Diethanolamide 
Magnesium Aluminum Silicate 
Hypromelloses 
Menthol 
DMDM Hydantoin 
Citric Acid Monohydrate 
Sodium Chloride 
Fd&C Blue No. 1 
D&C Red No. 33 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1995-53207 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/01/2012
Labeler - Rugby Laboratories, Inc. (191427277)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.103039178MANUFACTURE(0536-1995)

Revised: 1/2013
Document Id: 7dc73cf8-3e47-4b91-8b05-f9ce4a2dd460
Set id: f8942f2b-32fb-4a2d-b0cf-0f2d1c6974c2
Version: 1
Effective Time: 20130130
 
Rugby Laboratories, Inc.