Label: SODIUM SULFACETAMIDE liquid

  • NDC Code(s): 58657-477-06, 58657-477-12, 58657-477-16
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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.

Drug Label Information

Updated January 24, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Inactive Ingredients

    Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

  • Description

    Each gram contains 100 mg of sodium sulfacetamide in a vehicle consisting of:
    Butylated Hydroxytoluene, Citric Acid, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Stearyl Alcohol, Triacetin, Xanthan Gum.

  • Indications

    This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

  • Contraindications

    This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. This product is not to be used by patients with kidney disease.

  • Dosage and Administration

    Seborrheic dermatitis including seborrhea sicca - Wash affected areas twice daily (morning and evening) 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 working into a full lather, rinse thoroughly, pat dry and repeat after 10 to 20 seconds. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. lf skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. Regular shampooing following the use of this product is not necessary, but the hair should be shampooed at least once a week. As the condition subsides, the interval between
    applications may be lengthened. Applications once or twice weekly or every other week may prevent recurrence. Should the condition recur after stopping therapy, the application of this product should be reinitiated as at the beginning of treatment.


    Secondary cutaneous bacterial infections - Wash affected areas twice daily (morning and evening) 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 to 20 seconds working into a full lather, rinse thoroughly and pat dry. Rinsing with plain water will remove any excess medication. Repeat application as described above for 8 to 10 days or as directed by your physician. If skin dryness occurs it may be controlled by rinsing cleanser off sooner or using less frequently. See package insert for full prescribing information.

  • Warnings

    WARNING: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
    KEEP OUT OF REACH OF CHILDREN.

    Avoid contact with eyes, lips and mucous membranes.


    See label booklet for Full prescribing information.

  • Storage

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing and excessive heat. Keep bottle tightly closed.


    This bottle is not filled to the top but does contain 6 fl oz of product as identified on the front
    panel of the bottle.

    To report a serious adverse event or obtain product information, call (877) 250-3427.

  • Package

    label

    Manufactured in the U.S.A. for
    Method Pharmaceuticals, LLC
    Southlake, Texas 76092
    Rev 09/21

  • Package 12oz

    label

  • Package 16 oz

    label

  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE 
    sodium sulfacetamide liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-477
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-477-12355 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    2NDC:58657-477-16480 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    3NDC:58657-477-06177 g in 1 BOTTLE; Type 0: Not a Combination Product01/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/15/2022
    Labeler - Method Pharmaceuticals, LLC (060216698)