SEBEX- salicylic acid and 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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Sebex Shampoo

Active ingredient

Colloidal sulfur, 2%
Salicylic acid, 2%

Purpose

 Antidandruff

Use

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

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

Other information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1962
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid 20 mg  in 1000 mL
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur 20 mg  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTOXYNOL-1 (UNII: 20CAX7IO75)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
LANOLIN (UNII: 7EV65EAW6H)  
WATER (UNII: 059QF0KO0R)  
QUATERNIUM-15 (UNII: E40U03LEM0)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
Color BLUE (Aqua Blue) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-1962-97 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: 8555f7dc-82d1-49c1-b68a-69cde8b12b55
Set id: aec81d61-1d28-490f-9654-f66bd4a30ffa
Version: 2
Effective Time: 20130114
 
Rugby Laboratories