SEBEX- salicylic acid, colloidal sulfur shampoo

Sebex by

Drug Labeling and Warnings

Sebex by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Garcoa, Inc., Sigan Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SEBEX 
salicylic acid, colloidal sulfur shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1962
Route of Administration	TOPICAL

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
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)
Octoxynol-1 (UNII: 20CAX7IO75)

Product Characteristics
Color	YELLOW	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; Type 0: Not a Combination Product	10/29/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	10/29/2012

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, Inc.		255106239	MANUFACTURE(0536-1962)