SELENIUM SULFIDE shampoo

Selenium sulfide by

Drug Labeling and Warnings

Selenium sulfide by is a Otc medication manufactured, distributed, or labeled by Sonar Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Selenium sulfide 1%

Purpose

Antidandruff

Use

for relief of flaking and itching due to dandruff and seborrheic dermatitis and to help prevent their recurrence.

Warnings

For external use only

Ask a doctor before use if you have

• seborrheic dermatitis in areas other than the scalp

When using this product

• avoid contact with 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.

Inactive Ingredients

water, ammonium lauryl sulfate, ammonium laureth sulfate, dihydrogenated tallow phthalic acid amide, sodium chloride, cocamide DEA, dimethicone, aloe barbadensis leaf juice, titanium dioxide, hydroxypropyl methylcellulose, sodium isostearyl lactylate, DMDM hydantoin, fragrance, citric acid, sodium citrate, FD&C blue no.1 (245-067)

SPL UNCLASSIFIED SECTION

Manufactured By:
Sonar Products, Inc.
609 Industrial Road
Carlstadt, NJ 07072

PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

NDC: 65255-409-88

SONAR PRODUCTS, INC.

SELENIUM
SULFIDE
1% SHAMPOO

Moisturizing Dandruff
Shampoo

11 Fl. Oz. (325 mL)

INGREDIENTS AND APPEARANCE

SELENIUM SULFIDE 
selenium sulfide shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65255-409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM - UNII:H6241UJ22B)	SELENIUM SULFIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE (UNII: 1R81RPY10G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	TURQUOISE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65255-409-03	325 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	02/08/2012

Labeler - Sonar Products, Inc (104283945)

Establishment
Name	Address	ID/FEI	Business Operations
Sonar Products, Inc		104283945	MANUFACTURE(65255-409) , LABEL(65255-409)