Selenium Sulfide 2.25% Shampoo

SELENIUM SULFIDE SHAMPOO  - selenium sulfide shampoo 
River's Edge Pharmaceuticals, LLC

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Selenium Sulfide 2.25% Shampoo

DESCRIPTION:

A liquid antiseborrheic,
antifungal preparation for topical application.

INGREDIENTS:

River’s Edge Selenium Sulfide
2.25% Shampoo contains Selenium Sulfide
2.25%, Ammonium Lauryl Sulfate,
Caprylic/Capric Triglyceride, Chromium Oxide
Green, Citric Acid, Cocamidopropyl Betaine, DandC
Yellow No. 8, Diazolidinyl Urea, Edetate
Disodium, FDandC Red No. 40, Fragrance,
Hydroxypropyl Methylcellulose, Magnesium
Aluminum Silicate, Methylparaben, Panthenol,
PPG-2 Hydroxyethyl Coco/Isostearamide,
Propylene Glycol, Propylparaben, Purified Water,
Sodium Citrate, Titanium Dioxide, Tocopheryl
Acetate, Urea and Zinc Pyrithione.

CLINICAL PHARMACOLOGY:

Selenium sulfide
appears to have a cytostatic effect on cells of
the epidermis and follicular epithelium, reducing
corneocyte production.

PHARMACOKINETICS:

The mechanism of action of
topically applied selenium sulfide is not yet known.

INDICATIONS AND USAGE:

A liquid antiseborrheic,
antifungal preparation for the treatment of
seborrheic dermatitis of the scalp, dandruff and
tinea versicolor. Urea hydrates and is useful for
conditions such as dry scalp.

CONTRAINDICATIONS:

Contraindicated in
persons with known or suspected hypersensitivity
to any of the listed ingredients.

WARNINGS:

For external use only. Not for
ophthalmic use. DO NOT USE ON BROKEN SKIN
OR INFLAMED AREAS. If allergic reaction
occurs, discontinue use. Avoid contact with
eyes, genital areas and skin folds, as irritation
and burning may result. These areas should be
thoroughly rinsed with water after application.

PRECAUTIONS:

This medication is to be used as
directed by a physician. Not to be used when
inflammation or exudation is present as
increased absorption may occur.

CARCINOGENESIS:

Dermal application of 25%
and 50% solutions of 2.5% selenium sulfide
lotion on mice over an 88-week period indicated
no carcinogenic effects.

USE IN PREGNANCY:

CATEGORY C. Animal
reproduction studies have not been conducted
with River’s Edge Selenium Sulfide 2.25%
Shampoo. It is also not known whether
Selenium Sulfide 2.25% Shampoo can cause
fetal harm when applied to the body surfaces of
a pregnant woman or can affect reproduction
capacity. Under ordinary circumstances,
Selenium Sulfide 2.25% Shampoo should not be
used by pregnant women.

NURSING MOTHERS:

It is not known whether or
not this drug is secreted in human milk.
Because many drugs are secreted in human
milk, caution should be exercised when River’s
Edge Selenium Sulfide 2.25% Shampoo is
administered to nursing women.

PEDIATRIC USE:

Safety and effectiveness in
children have not been established.

ADVERSE REACTIONS:

In decreasing order of
severity: skin irritation; occasional reports of
increase in normal hair loss; discoloration of
hair (can be avoided or minimized by thorough
rinsing of hair after treatment). As with other
shampoos, oiliness or dryness of hair and scalp
may occur.
Call your doctor for medical advice about
side effects. You may report side effects to
the FDA at 1-800-FDA-1088.

OVERDOSAGE:

No documented reports of
serious toxicity in humans resulting from acute
ingestion of River’s Edge Selenium Sulfide
2.25% Shampoo. However, acute toxicity
studies in animals suggest that ingestion of
large amounts could result in potential human
toxicity. Evacuation of the stomach contents
should be considered in cases of acute oral
ingestion.

DOSAGE AND ADMINISTRATION:

For
seborrheic dermatitis and dandruff: Generally 2
applications each week for 2 weeks will control
symptoms. Subsequently, shampoo may be
used less frequently – weekly, every 2 weeks,
every 3 to 4 weeks or as directed by a
physician. Should not be applied more
frequently than necessary to maintain control.
For tinea versicolor: Apply to affected areas and
lather with a small amount of water. Allow
product to remain on skin for 10 minutes, then
rinse thoroughly. Repeat procedure once a day
for seven days or as directed by a physician.

HOW SUPPLIED:

River’s Edge Selenium
Sulfide 2.25% Shampoo is supplied in a 180
mL bottle, NDC 68032-127-18.
Store at controlled room temperature 15°-30°C
(59°-86°F). Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF
THE REACH OF CHILDREN.

PACKAGING:

NDC 68032-127-18

Selenium Sulfide 2.25% Shampoo

Rx Only

Selenium Sulfide in a Urea Vehicle with Zinc Pyrithione

Topical Therapy for the Treatment of:

INDICATIONS AND USES: A liquid
antiseborrheic, antifungal preparation for
the treatment of seborrheic dermatitis of the
scalp, dandruff and tinea versicolor. Urea
hydrates and is useful for conditions such
as dry scalp.

DOSAGE AND ADMINISTRATION:
For seborrheic dermatitis and dandruff.
Generally 2 applications each week for 2
weeks will control symptoms. Subsequently,
shampoo may be used less frequentlyweekly,
every 2 weeks, every 3 to 4 weeks
or as directed by a physician. Should not be
applied more frequently than necessary to
maintain control.

For Tinea Versicolor: Apply to affected
areas and lather with a small amount of
water. Allow product to remain on skin for
10 minutes, then rinse thoroughly. Repeat
procedure once a day for 7 days or as
directed by a physician.

CAUTION: For external use only. Not for
ophthalmic use. DO NOT USE ON BROKEN

SKIN OR INFLAMED AREAS.
If allergic reaction occurs, discontinue use.
avoid contact with eyes, genital areas and
skin folds as irritation and burning may
result. These areas should be thoroughly
rinsed after application.

INGREDIENTS: Each gram of River’s Edge
Selenium Sulfide 2.25% Shampoo
contains Selenium Sulfide 2.25%,
Ammonium Lauryl Sulfate, Caprylic/Capric
Triglyceride, Chromium Oxide Green, Citric
Acid, Cocamidopropyl Betaine, DandC Yellow
No. 8, Diazolidinyl Urea, Edetate Disodium,
FDandC Red No. 40, Fragrance,
Hydroxypropyl Methylcellulose, Magnesium
Aluminum Silicate, Methylparaben,
Panthenol, PPG-2 Hydroxyethyl
Coco/Isostearamide, Propylene Glycol,
Propylparaben, Purified Water, Sodium
Citrate, Titanium Dioxide, Tocopheryl
Acetate, Urea and Zinc Pyrithione.

KEEP THIS AND ALL MEDICATIONS
OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature
15º-30ºC (59º-86ºF).

Protect from freezing.

Please see package insert for full
Prescribing Information.
Selenium Sulfide 2.25% Shampoo Packaging1


SELENIUM SULFIDE SHAMPOO 
selenium sulfide 2.25% shampoo   shampoo
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-127
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SELENIUM SULFIDE (SELENIUM) SELENIUM SULFIDE2.25   in 180 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-127-18180 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other12/08/2008

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 11/2009River's Edge Pharmaceuticals, LLC