Sodium Sulfacetamide and Sulfur Wash
Name: Sodium Sulfacetamide and Sulfur Wash
Indications
This product is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
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.
Adverse reactions
Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
Dosage and administration
Wash affected areas once or twice daily, or as directed by your physician. 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. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.
How supplied
This product is supplied in the following size(s): 16 oz. (454 g) bottles, NDC 44523-605-16
To report a serious adverse event or obtain product information, call 1-866-762-2365.
Manufactured for:
BIOCOMP PHARMA ®, INC.
San Antonio, TX 78230 1355
826175 I826175R0415
Carton
| Established Pharmacological Class |
| Substance | Pharmacological Class | | Daily Moisturizing | Lotions, Oils, Powders, and Creams | |
SODIUM SULFACETAMIDE AND SULFUR
sodium sulfacetamide, sulfur kit |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:44523-609 | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:44523-609-23 | 1 KIT in 1 CARTON | |
| Quantity of Parts | | Part # | Package Quantity | Total Product Quantity | | Part 1 | 1 BOTTLE, PLASTIC | 454 g | | Part 2 | 1 BOTTLE, PLASTIC | 473 mL | |
| Part 1 of 2 | SODIUM SULFACETAMIDE AND SULFUR
sodium sulfacetamide, sulfur lotion | |
| Product Information | | Item Code (Source) | NDC:44523-605 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | SULFACETAMIDE SODIUM (SULFACETAMIDE) | SULFACETAMIDE SODIUM | 90 mg in 1 g | | SULFUR (SULFUR) | SULFUR | 45 mg in 1 g | |
| Inactive Ingredients | | Ingredient Name | Strength | | MAGNESIUM ALUMINUM SILICATE | | | PEG-150 DISTEARATE | | | POLYETHYLENE GLYCOL 400 | | | WATER | | | CETYL ALCOHOL | | | EDETATE DISODIUM ANHYDROUS | | | GLYCERYL MONOSTEARATE | | | SODIUM THIOSULFATE | | | STEARYL ALCOHOL | | | PEG-100 STEARATE | | | BENZYL ALCOHOL | | | PHENOXYETHANOL | | | SODIUM LAURYL SULFATE | | | XANTHAN GUM | | |
| Product Characteristics | | Color | yellow (light yellow) | Score | | | Shape | | Size | | | Flavor | | Imprint Code | | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:44523-605-16 | 454 g in 1 BOTTLE, PLASTIC | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | unapproved drug other | | 04/15/2011 | | |
| Part 2 of 2 | DAILY MOISTURIZING
cream | |
| Product Information | | | Route of Administration | TOPICAL | DEA Schedule | | |
| Ingredients | | Ingredient Name | Quantity | | WATER | | | COCAMIDOPROPYL BETAINE | | | ALOE VERA LEAF | | | DISODIUM LAURETH SULFOSUCCINATE | | | CITRIC ACID MONOHYDRATE | | | GLYCOL STEARATE | | | GLYCERIN | | | PHENOXYETHANOL | | | MENTHA ARVENSIS LEAF OIL | | | EDETATE DISODIUM ANHYDROUS | | | METHYLPARABEN | | | BUTYLPARABEN | | | ETHYLPARABEN | | | PROPYLPARABEN | | | SORBITAN MONOLAURATE | | |
|
| Packaging | | # | Item Code | Package Description | | 1 | | 473 mL in 1 BOTTLE, PLASTIC | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Cosmetic | | 04/15/2011 | | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | unapproved drug other | | 04/15/2011 | | |
| Labeler - BioComp Pharma, Inc. (829249718) |
Revised: 04/2017 BioComp Pharma, Inc.
