RUGBY ANTI-DANDRUFF- selenium sulfide shampoo

Rugby Anti-Dandruff by

Drug Labeling and Warnings

Rugby Anti-Dandruff 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium Sulfide 1%

Purpose

Anti-seborrheic dermatitis, anti-dandruff

Uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

For external use only

As a doctor before use if

• ♦ condition covers a large area of the body.

When using this product

• ♦ avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• ♦ for color-treated or permed hair, rinse thoroughly.

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 right away.

Directions

• ♦ shake well
• ♦ shampoo, then rinse thoroughly
• ♦ for best results, use at least twice a week or as directed by a doctor.

Other information

store at room temperature

Inactive ingredients

water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33

Questions or comments?

1-866-645-2158

SPL UNCLASSIFIED SECTION

Distributed by: Rugby Laboratories
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

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

7 fl oz
(207 mL)

05-2675A

INGREDIENTS AND APPEARANCE

RUGBY ANTI-DANDRUFF 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1995
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q)	Selenium Sulfide	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ammonium Laureth-2 Sulfate (UNII: 698O4Z48G6)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Coco Diethanolamide (UNII: 92005F972D)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
Menthol, unspecified form (UNII: L7T10EIP3A)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
DMDM Hydantoin (UNII: BYR0546TOW)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Sodium Chloride (UNII: 451W47IQ8X)
Fd&C Blue No. 1 (UNII: H3R47K3TBD)
D&C Red No. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1995-53	207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	05/01/2012

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, Inc.		255106239	MANUFACTURE(0536-1995)