SEBEX  ANTIDANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS- salicylic acid, sulfur shampoo 
Rugby Laboratories

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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Rugby Sebex Medicated Dandruff, Seborrheic Dermatitis, and Psoriasis Shampoo

Drug Facts

Active ingredientsPurpose
Salicylic Acid, 2% }
Sulfur, 2%		Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Uses

controls the symptoms of:

  • dandruff
  • seborrheic dermatitis
  • psoriasis

Warnings

For external use only

Do not use

  • If condition covers a large area of the body, consult your doctor before using this product
  • this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

When using this product

  • avoid contact with eyes
  • If contact occurs, rinse eyes thoroughly with water

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 (1-800-222-1222) right away.

Directions

  • SHAKE WELL BEFORE USE
  • wet the scalp or skin and massage in enough shampoo to work up a lather
  • massage for 3-5 minutes and rinse out thoroughly
  • repeat application and rinse thoroughly again
  • for best results, use at least twice a week or as directed by a doctor

Other information

  • store at room temperature
  • see container for Lot No. & Exp. date

Inactive ingredients

water, sodium lauryl sulfate, disodium cocoamphodipropionate, acrylates copolymer, citric acid, PEG-75 lanolin, fragrance, quaternium-15, diethylhexyl sodium sulfosuccinate, isopropyl palmitate, sodium hydroxide.

Questions or comments?

1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Rugby®

NDC 0536-1962-97

Sebex

Medicated Dandruff,
Seborrheic Dermatitis,
and Psoriasis Shampoo

4 FL OZ (118 mL)

Principal Display Panel - 118 mL Bottle Label
SEBEX   ANTIDANDRUFF, ANTI-SEBORRHEIC DERMATITIS, ANTI-PSORIASIS
salicylic acid, sulfur shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1962
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid20 mg  in 1000 mL
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur20 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
PEG-75 Lanolin (UNII: 09179OX7TB)  
Quaternium-15 (UNII: E40U03LEM0)  
Docusate Sodium (UNII: F05Q2T2JA0)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1962-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/29/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H10/29/2012
Labeler - Rugby Laboratories (079246066)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries, Inc.255106239MANUFACTURE(0536-1962)

Revised: 1/2022
Document Id: ccd4e61e-a839-4a49-a6d5-d9c4b9afd118
Set id: aec81d61-1d28-490f-9654-f66bd4a30ffa
Version: 5
Effective Time: 20220113
 
Rugby Laboratories