GOODSENSE MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo

GoodSense Medicated Dandruff by

Drug Labeling and Warnings

GoodSense Medicated Dandruff by is a Otc medication manufactured, distributed, or labeled by Geiss, Destin & Dunn, Inc., 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

Ask 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

SPL UNCLASSIFIED SECTION

Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

GOODSENSE®

Medicated

Selenium Sulfide 1%
Dandruff
Shampoo

Maximum
Medicated Control
Healthier Hair
Healthier Scalp

Compare to active ingredient of
Selsun Blue® Medicated
Dandruff Shampoo
100%
SATISFACTION
GUARANTEED

11 FL. OZ. (325 mL)

05-1788B

INGREDIENTS AND APPEARANCE

GOODSENSE MEDICATED DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-883
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-5 SULFATE (UNII: 43ZIH89I48)
Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Chlorphenesin (UNII: I670DAL4SZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
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: 50804-883-01	325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	03/01/2018

Labeler - Geiss, Destin & Dunn, Inc. (076059836)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC		255106239	MANUFACTURE(50804-883)