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NDC 58657-0479-06 Selenium Sulfide 23 mg/mL Details
Selenium Sulfide 23 mg/mL
Selenium Sulfide is a TOPICAL SHAMPOO in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Method Pharmaceuticals, LLC. The primary component is SELENIUM SULFIDE.
MedlinePlus Drug Summary
Selenium sulfide, an anti-infective agent, relieves itching and flaking of the scalp and removes the dry, scaly particles that are commonly referred to as dandruff or seborrhea. It is also used to treat tinea versicolor, a fungal infection of the skin. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 58657-0479-06Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Selenium Sulfide
Product Information
| NDC | 58657-0479 |
|---|---|
| Product ID | 58657-479_edb45735-0ae1-e697-e053-2a95a90a000f |
| Associated GPIs | 90300050004530 |
| GCN Sequence Number | 071430 |
| GCN Sequence Number Description | selenium sulfide SHAMPOO 2.3 % TOPICAL |
| HIC3 | L5E |
| HIC3 Description | ANTISEBORRHEIC AGENTS |
| GCN | 35212 |
| HICL Sequence Number | 013406 |
| HICL Sequence Number Description | SELENIUM SULFIDE |
| Brand/Generic | Generic |
| Proprietary Name | Selenium Sulfide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | selenium sulfide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SHAMPOO |
| Route | TOPICAL |
| Active Ingredient Strength | 23 |
| Active Ingredient Units | mg/mL |
| Substance Name | SELENIUM SULFIDE |
| Labeler Name | Method Pharmaceuticals, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 58657-0479-06 (58657047906)
| NDC Package Code | 58657-479-06 |
|---|---|
| Billing NDC | 58657047906 |
| Package | 180 mL in 1 BOTTLE (58657-479-06) |
| Marketing Start Date | 2018-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ddf1d2bd-26ad-47a2-95b3-c5405a90016d Details
SPL UNCLASSIFIED SECTION
Selenium Sulfide 2.3% Shampoo
Rx Only
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
DESCRIPTION: Each mL contains 23 mg of selenium sulfide in a vehicle consisting of: alpha-tocopherol acetate, ammonium lauryl sulfate, citrus fragrance, cocamidopropyl betaine, EDTA, FD&C red No. 40, FD&C yellow No. 10, methyl paraben, panthenol, propyl paraben, purified water, pyrithione zinc, urea, xanthan gum.
CLINICAL PHARMACOLOGY:
INDICATIONS:
CONTRAINDICATIONS:
PRECAUTIONS:
General:
This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Information for Patients:
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes. If accidental contact occurs, rinse thoroughly with water. Do not use on broken skin or inflamed areas.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects. Studies on reproduction and fertility also have not been performed.
Pregnancy:
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
ADVERSE REACTIONS:
OVERDOSAGE:
There are no documented reports of serious toxicity in humans resulting from acute ingestion of this product. However, acute toxicity studies in animals suggest that ingestion of large amounts could result in potential human toxicity. Evacuation of the stomach contents should be considered in cases of acute oral ingestion.
DOSAGE AND ADMINISTRATION:
Shake well before use.
For seborrheic dermatitis and dandruff: Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Rinse thoroughly and pat dry. Generally, two applications each week for two weeks will control symptoms. Subsequently, shampoo may be used less frequently or as directed by a physician. It should not be applied more frequently than necessary to maintain control.
For tinea versicolor: Wet skin and apply to areas to be cleansed. Massage gently into the skin working into a full lather. Allow product to remain on skin for ten minutes, then rinse thoroughly and pat dry. Repeat procedure once a day for seven days or as directed by a physician.
STORAGE:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE: Protect from freezing and excessive heat. The product may darken upon storage. Discoloration does not impair the efficacy or safety of the product. Keep container tightly closed.
HOW SUPPLIED:
This product is supplied in the following size(s): 6 fl. oz. (180 mL) bottles, NDC 58657-479-06
To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at [email protected]; or call FDA at (800) FDA-1088.
Manufactured For:
Method Pharmaceuticals, LLC Fort Worth, Texas 76118
Rev. 02/2018
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| SELENIUM SULFIDE
selenium sulfide shampoo |
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| Labeler - Method Pharmaceuticals, LLC (060216698) |