SUMAXIN CLEANSING PADS- sulfacetamide sodium and sulfur cloth SUMAXIN CP- sulfacetamide sodium and sulfur kit

Sumaxin CP by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

In a vehicle containing Green Tea & Aloe

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 pad of Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation. Each gram of this cleanser-based formulation contains 100 mg of Sodium Sulfacetamide and 40 mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl stearate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.

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 10% & sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

CONTRAINDICATIONS

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are 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 10% & sulfur 4%) Cleansing Pads. It is also not known whether Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads 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 10% & sulfur 4%) Cleansing Pads. 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 10% & sulfur 4%) Cleansing Pads 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

Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.

HOW SUPPLIED

Sumaxin® (sodium sulfacetamide 10% & sulfur 4%) Cleansing Pads are available in boxes of 60 cloths (3.7 g), NDC: 43538-100-60.

Store at 15°-30° C (59°-86° F).

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.

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

IP001-R5
Rev. 10/17

PRINCIPAL DISPLAY PANEL - 60 Pad Carton

NDC: 43538-100-60

Rx Only
sumaxin®
(sodium sulfacetamide 10% & sulfur 4%)
Cleansing Pads

In a vehicle containing Green Tea & Aloe

60 Cleansing Pads
Net wt. 3.7 g Each

MEDIMETRIKS
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC: 43538-101-60

Rx Only
sumaxin®
(Sodium Sulfacetamide 10%
& Sulfur 4%) Cleansing Pads
CP
KIT

CONTENTS:

• 1 - Sumaxin® (Sodium Sulfacemide 10% & Sulfur 4%)
  Cleansing Pads Carton - 60 Pads (Net wt. 3.7 g each)
• 1 - Rehyla® Wash Moisturizing Daily Wash (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.

INGREDIENTS AND APPEARANCE

SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43538-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)	Sulfacetamide sodium	100 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)
glycerin (UNII: PDC6A3C0OX)
green tea leaf (UNII: W2ZU1RY8B0)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cocoyl isethionate (UNII: 518XTE8493)
sodium lauryl sulfoacetate (UNII: D0Y70F2B9J)
sodium thiosulfate (UNII: HX1032V43M)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-100-60	60 in 1 CARTON	01/01/2009
1		3.7 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/01/2009

SUMAXIN CP 
sulfacetamide sodium and sulfur kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 43538-101

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43538-101-60	1 in 1 CARTON	08/01/2011

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	60 PACKET	222 g
Part 2	1 BOTTLE, PUMP	454 g

Part 1 of 2

SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5)	sulfacetamide sodium	100 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)
glycerin (UNII: PDC6A3C0OX)
green tea leaf (UNII: W2ZU1RY8B0)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)
sodium cocoyl isethionate (UNII: 518XTE8493)
sodium lauryl sulfoacetate (UNII: D0Y70F2B9J)
sodium thiosulfate (UNII: HX1032V43M)
stearyl alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		60 in 1 CARTON
1		3.7 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/01/2009

Part 2 of 2

REHYLA WASH 
cleansing (cold creams, cleansing lotions, liquids, and pads)

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	water (UNII: 059QF0KO0R)
INGR	glyceryl monostearate (UNII: 230OU9XXE4)
INGR	glycerin (UNII: PDC6A3C0OX)
INGR	cetyl alcohol (UNII: 936JST6JCN)
INGR	disodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)
INGR	cholesterol (UNII: 97C5T2UQ7J)
INGR	disodium laureth sulfosuccinate (UNII: D6DH1DTN7E)
INGR	helianthus annuus seed wax (UNII: 42DG15CHXV)
INGR	caprylyl glycol (UNII: 00YIU5438U)
INGR	propylene glycol (UNII: 6DC9Q167V3)
INGR	phenoxyethanol (UNII: HIE492ZZ3T)
INGR	sodium cocoyl isethionate (UNII: 518XTE8493)
INGR	cocamidopropyl betaine (UNII: 5OCF3O11KX)
INGR	sodium methyl cocoyl taurate (UNII: JVL98CG53G)
INGR	C13-14 isoparaffin (UNII: E4F12ROE70)
INGR	sodium chloride (UNII: 451W47IQ8X)
INGR	niacinamide (UNII: 25X51I8RD4)
INGR	edetate disodium (UNII: 7FLD91C86K)
INGR	hexylene glycol (UNII: KEH0A3F75J)
INGR	laureth-7 (UNII: Z95S6G8201)
INGR	chamaemelum nobile flower (UNII: O2T154T6OG)
INGR	hyaluronate sodium (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 CARTON
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
Cosmetic		08/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		08/01/2011

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Establishment
Name	Address	ID/FEI	Business Operations
IGI Laboratories		011036910	MANUFACTURE(43538-100, 43538-101)