Sodium Sulfacetamide 10%

Sodium Sulfacetamide 10%
SPL v100
SPL
SPL Set ID acd3fb4a-558d-4565-84d8-23a0d917eab6
Route
TOPICAL
Published
Effective Date 2024-12-26
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfacetamide (100 mg)
Inactive Ingredients
Glycerin Glyceryl Monostearate Peg-100 Stearate Phenoxyethanol Butylated Hydroxytoluene Triacetin Sodium Thiosulfate Stearyl Alcohol Cetyl Alcohol Cocamidopropyl Betaine Edetate Disodium Anhydrous Citric Acid Monohydrate Water Sodium Laureth-3 Sulfate Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-01-15

Description

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.

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.

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.

How Supplied

Sodium Sulfacetamide 10% NDC 72162-1665-2: 355 g in a BOTTLE NDC 72162-1665-4: 480 g in a BOTTLE NDC 72162-1665-7: 177 g in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504


Medication Information

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.

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.

How Supplied

Sodium Sulfacetamide 10%

  • NDC 72162-1665-2: 355 g in a BOTTLE
  • NDC 72162-1665-4: 480 g in a BOTTLE
  • NDC 72162-1665-7: 177 g in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

Section 51945-4

Sodium Sulfacetamide 10%

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.

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.

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.

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.


Structured Label Content

Section 51945-4 (51945-4)

Sodium Sulfacetamide 10%

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.

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.

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.

How Supplied (HOW SUPPLIED)

Sodium Sulfacetamide 10%

  • NDC 72162-1665-2: 355 g in a BOTTLE
  • NDC 72162-1665-4: 480 g in a BOTTLE
  • NDC 72162-1665-7: 177 g in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

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.

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.

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.


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