SUMAXIN WASH- sulfacetamide sodium and sulfur lotion

Sumaxin Wash by

Drug Labeling and Warnings

Sumaxin Wash by is a Prescription medication manufactured, distributed, or labeled by Medimetriks Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

In a vehicle containing Green Tea & Aloe

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 mg of Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash contains 90 mg of sodium sulfacetamide and 40 mg of sulfur in a formulation consisting of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glyceryl stearate/PEG-100 stearate, green tea, magnesium aluminum silicate, methylparaben, 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-Fildes 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

Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is not to be used by patients with kidney disease.

WARNINGS

Although 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. 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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash. It is also not known whether Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash 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 Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash. However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash are 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.

DOSAGE AND ADMINISTRATION

Apply Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash once or twice daily to affected areas, or as directed by your physician. 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 off Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash sooner or using less often.

HOW SUPPLIED

Sumaxin® (sodium sulfacetamide 9% & sulfur 4%) Wash is available in a 16 oz (454 g) bottle, NDC: 43538-130-16.

Store at controlled room temperature 15°-30° C (59°-86° F). Protect from freezing.

SPL UNCLASSIFIED SECTION

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc., at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP009-R3
Rev. 10/17

PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton

NDC: 43538-130-16

Rx Only
sumaxin®
(sodium sulfacetamide 9% & sulfur 4%)
WASH

In a vehicle containing
Green Tea & Aloe

Net Wt. 16 oz. (454 g)

MEDIMETRIKS
PHARMACEUTICALS, INC.

INGREDIENTS AND APPEARANCE

SUMAXIN WASH 
sulfacetamide sodium and sulfur lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43538-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfacetamide Sodium (UNII: 4NRT660KJQ) (Sulfacetamide - UNII:4965G3J0F5)	Sulfacetamide Sodium	90 mg  in 1 g
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
aloe (UNII: V5VD430YW9)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cetyl alcohol (UNII: 936JST6JCN)
disodium oleamido monoethanolamine sulfosuccinate (UNII: 5M1101WGSY)
edetate disodium (UNII: 7FLD91C86K)
green tea leaf (UNII: W2ZU1RY8B0)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cocoyl isethionate (UNII: 518XTE8493)
sodium methyl cocoyl taurate (UNII: JVL98CG53G)
sodium thiosulfate (UNII: HX1032V43M)
stearyl alcohol (UNII: 2KR89I4H1Y)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-130-16	1 in 1 CARTON	10/30/2009
1		454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/30/2009

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)