SUMAXIN  CLEANSING PADS- sulfacetamide sodium and sulfur cloth 
SUMAXIN CP- sulfacetamide sodium and sulfur 
Medimetriks Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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:

Chemical Structure

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).

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 - 60 Pad Carton

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.

PRINCIPAL DISPLAY PANEL - Kit Carton
SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5) Sulfacetamide sodium100 mg  in 1 g
Sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) Sulfur40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43538-100-6060 in 1 CARTON01/01/2009
13.7 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/2009
SUMAXIN CP 
sulfacetamide sodium and sulfur kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43538-101
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43538-101-601 in 1 CARTON08/01/2011
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 160 PACKET 222 g
Part 21 BOTTLE, PUMP 454 g
Part 1 of 2
SUMAXIN   CLEANSING PADS
sulfacetamide sodium and sulfur cloth
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5) sulfacetamide sodium100 mg  in 1 g
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
160 in 1 CARTON
13.7 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/2009
Part 2 of 2
REHYLA WASH 
bath soaps and body washes [personal cleanliness]
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRwater (UNII: 059QF0KO0R)  
INGRglyceryl monostearate (UNII: 230OU9XXE4)  
INGRglycerin (UNII: PDC6A3C0OX)  
INGRcetyl alcohol (UNII: 936JST6JCN)  
INGRdisodium oleamido mipa-sulfosuccinate (UNII: 0MBZ20845F)  
INGRcholesterol (UNII: 97C5T2UQ7J)  
INGRdisodium laureth sulfosuccinate (UNII: D6DH1DTN7E)  
INGRhelianthus annuus seed wax (UNII: 42DG15CHXV)  
INGRcaprylyl glycol (UNII: 00YIU5438U)  
INGRpropylene glycol (UNII: 6DC9Q167V3)  
INGRphenoxyethanol (UNII: HIE492ZZ3T)  
INGRsodium cocoyl isethionate (UNII: 518XTE8493)  
INGRcocamidopropyl betaine (UNII: 5OCF3O11KX)  
INGRsodium methyl cocoyl taurate (UNII: JVL98CG53G)  
INGRC13-14 isoparaffin (UNII: E4F12ROE70)  
INGRsodium chloride (UNII: 451W47IQ8X)  
INGRniacinamide (UNII: 25X51I8RD4)  
INGRedetate disodium (UNII: 7FLD91C86K)  
INGRhexylene glycol (UNII: KEH0A3F75J)  
INGRlaureth-7 (UNII: Z95S6G8201)  
INGRchamaemelum nobile flower (UNII: O2T154T6OG)  
INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
1454 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic08/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/01/2011
Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)
Establishment
NameAddressID/FEIBusiness Operations
Marketing Advertising Promotions, Inc.797063526PACK(43538-101)

Revised: 12/2023
Document Id: 10983826-2970-4ff2-87f6-6633c093843f
Set id: 5d9ddc1a-fbae-4595-86ce-3bbca7d03482
Version: 3
Effective Time: 20231215
 
Medimetriks Pharmaceuticals, Inc.