FDA Label for Exact-rx Sodium Sulfacetamide And Sulfer 10%/5% Cleanser

Indications & Usage

INDICATIONS: Sodium Sulfacetemide 10% and Sulfer 5% Cleanser

is indicated for he topical control of acne vulgaris, acne rosacea and

seborrheic dermatitis.

Dosage & Administration

DIRECTIONS FOR USE: Wash affected area once or twice daily, or

as directed by your physician. Avoid contat with eyes or mucous

membranes. Wet skin and liberally apply to areas to be cleansed,

massage gently into skin for 10-20 seconds working into a full lather, rinse

thoroughly and pat dry. if drying occurs, it may be controlled by rinsing

cleanser off sooner or using less often. See package insert for complete product information.

Warnings

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR

OPHTHALMIC USE. (KEEP AWAY FROM EYES).

KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

In case of accidental ingestion contact a poison

control center immediately. Keep container tightly closed.

Contraindications

CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfer 5% Cleanser is

contraindicated in persons with know or suspected hypersensitivity to sulfonamides,

sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5%

Cleanser is not to be used by patients with kidney disease.

CAUTION: If redness or irritaiton occurs, discontinue use.

Inactive Ingredient

Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cleanser containing ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, guar gum, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

Storage And Handling

Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing.

See bottle for lot number and expiration date

Description

Manufactured in the U.S.A. for

Exact-Rx, Inc., Melville, NY 11747

Spl Patient Package Insert

Sodium Sulfacetamide 10% &
Sulfur 5% Cleanser
Rx Only
DESCRIPTION: Sodium sulfacetamide is a sulfonamide with
antibacterial activity while sulfur acts as a keratolytic agent. Chemically
sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide,
monosodium salt, monohydrate. The structural formula is:
Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser
contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a
cleanser containing butylated hydroxytoluene, cetyl alcohol, disodium
EDTA, disodium oleamido MEA-sulfosuccinate, glyceryl stearate,
magnesium aluminum silicate, methylparaben, PEG-100 stearate,
petrolatum, propylene glycol, propylparaben, purified water, sodium
cocoyl isethionate, sodium methyl cocoyl taurate, sodium thiosulfate,
stearyl alcohol, xanthan gum.
CLINICAL PHARMACOLOGY: The most widely accepted mechanism of
action of sulfonamides is the Woods-Fields theory which is based on the
fact that sulfonamides act as competitive antagonists to para-aminobenzoic
acid (PABA), an essential component for bacterial growth. While
absorption through intact skin has not been determined, sodium
sulfacetamide is readily absorbed from the gastrointestinal tract when
taken orally and excreted in the urine, largely unchanged. The biological
half-life has variously been reported as 7 to 12.8 hours. The exact mode
of action of sulfur in the treatment of acne is unknown but it has been
reported that it inhibits the growth of Propionibacterium acnes and the
formation of free fatty acids.
INDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is
indicated in the topical control of acne vulgaris, acne rosacea and
seborrheic dermatitis.
CONTRAINDICATIONS: Sodium Sulfacetamide 10% & Sulfur 5%
Cleanser is contraindicated for use by patients having known
hypersensitivity to sulfonamides, sulfur or any other component of this
preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to
be used by patients with kidney disease.
WARNINGS: Although it is rare, sensitivity to sodium sulfacetamide may
occur. Therefore, caution and careful supervision should be observed
when prescribing this drug for patients who may be prone to
hypersensitivity to topical sulfonamides. Systemic toxic reactions such
as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug
fever, jaundice, and contact dermatitis indicate hypersensitivity to
sulfonamides. Particular caution should be employed if areas of denuded
or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes.
KEEP OUT OF REACH OF CHILDREN.
In case of accidental ingestion contact a poison control center
immediately. Keep container tightly closed.
PRECAUTIONS: General: If irritation develops, use of the product should
be discontinued and appropriate therapy instituted. Patients should be
carefully observed for possible local irritation or sensitization during
long-term therapy. The object of this therapy is to achieve
desquamation without irritation, but sodium sulfacetamide and sulfur
can cause reddening and scaling of the epidermis. These side effects
are not unusual in the treatment of acne vulgaris, but patients should be
cautioned about the possibility.
Information for Patients: Avoid contact with eyes, eyelids, lips and
mucous membranes. If accidental contact occurs, rinse with water. If
excessive irritation develops, discontinue use and consult your
physician.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term studies in animals have not been performed to evaluate
carcinogenic potential.
Pregnancy: Category C. Animal reproduction studies have not been
conducted with Sodium Sulfacetamide 10% & Sulfur 5% Cleanser. It is
also not known whether Sodium Sulfacetamide 10% & Sulfur 5%
Cleanser can cause fetal harm when administered to a pregnant woman
or can affect reproduction capacity. Sodium Sulfacetamide 10% &
Sulfur 5% Cleanser should be given to a pregnant woman only if clearly
needed.
Nursing Mothers: It is not known whether sodium sulfacetamide is
excreted in the human milk following topical use of Sodium
Sulfacetamide 10% & Sulfur 5% Cleanser. However, small amounts of
orally administered sulfonamides have milk. In view of this and because
many drugs are excreted in human milk, caution should be exercised
when Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is administered
to a nursing woman.
Pediatric Use: Safety and effectiveness in children under the age of 12
have not been established.
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may
cause local irritation.
Call your doctor for medical advice about side effects.
DOSAGE AND ADMINISTRATION: Wash affected areas once or twice
daily, or as directed by your physician. Avoid contact with eyes or
mucous membranes. Wet skin and liberally apply to areas to be
cleansed, massage gently into skin for 10-20 seconds working into a
full lather, rinse thoroughly and pat dry. If drying occurs, it may be
controlled by rinsing cleanser off sooner or using less often.
HOW SUPPLIED: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is
available in a 6 oz (170 g) bottle, NDC 42808-113-06 and a 12 oz (340
g) bottle, NDC 42808-113-12.
Store at 20 to 25°C (68 to 77°F). See USP Controlled Room Temperature.
Protect from freezing.
Manufactured in the U.S.A. for
Exact-Rx, Inc., Melville, NY 11747
00-113-205-00
Iss:01

Package Label.Principal Display Panel

113-12 - 113 12