Your browser does not support JavaScript! SEBEX (SALICYLIC ACID, COLLOIDAL SULFUR) SHAMPOO [RUGBY LABORATORIES]
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SEBEX (salicylic acid, colloidal sulfur) shampoo
[Rugby Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Colloidal sulfur, 2%
Salicylic acid, 2%

Purpose

 Antidandruff

Use

  • Controls the symptoms of:

    -Dandruff
    -Seborrheic dermatitis
    -Psoriasis

Warning

 For external use only

For external use only

 For external use only

Do not use

 Do not use for seborrheic dermatitis or psoriasis if condition covers a large area of the body

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

  • avoid contact with eyes
  • if contact occurs, rise eyes thoroughly with water

Stop use and ask a doctor if

condition worsens or does not improve after regular use

Pregnancy/breast-feeding warning

Keep out of reach of children

 If swallowed, get meidcal help or contact a Poison Control Center 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 Number and Expiration Date

Inactive ingredients

Disodium cocoamphodipropionate, docusate sodium, fragrance, hydrochloric acid, isopropyl palmitate, octoxynol-1, PEG 85 lanolin, purified water, quaternium-15, sodium lauryl sulfate

Questions?

Questions or comments?
Call 1-800-645-2158

Principal Display Panel

SEBEX
Medicated Dandruff, Seborrheic Dermatitis &
Psoriasis Shampoo

Sebex

SEBEX 
salicylic acid, colloidal sulfur shampoo
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-1962
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
salicylic acid (salicylic acid) salicylic acid20 mg  in 1000 mL
sulfur (sulfur) sulfur20 mg  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
DISODIUM COCOAMPHODIPROPIONATE 
DOCUSATE SODIUM 
HYDROCHLORIC ACID 
ISOPROPYL PALMITATE 
OCTOXYNOL-1 
PEG-8 STEARATE 
LANOLIN 
WATER 
QUATERNIUM-15 
SODIUM LAURYL SULFATE 
Product Characteristics
ColorBLUE (Aqua Blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1962-97118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
 
Rugby Laboratories

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