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NDC 42582-0900-06 Selenium Sulfide 22.5 mg/mL Details
Selenium Sulfide 22.5 mg/mL
Selenium Sulfide is a TOPICAL SHAMPOO in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bi-Coastal Pharma International 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: 42582-0900-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Selenium Sulfide
Product Information
| NDC | 42582-0900 |
|---|---|
| Product ID | 42582-900_f3246e99-3f2b-49a3-80d2-015e59fd980d |
| Associated GPIs | 90300050004525 |
| GCN Sequence Number | 058399 |
| GCN Sequence Number Description | selenium sulfide SHAMPOO 2.25 % TOPICAL |
| HIC3 | L5E |
| HIC3 Description | ANTISEBORRHEIC AGENTS |
| GCN | 23824 |
| 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 | 22.5 |
| Active Ingredient Units | mg/mL |
| Substance Name | SELENIUM SULFIDE |
| Labeler Name | Bi-Coastal Pharma International 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 42582-0900-06 (42582090006)
| NDC Package Code | 42582-900-06 |
|---|---|
| Billing NDC | 42582090006 |
| Package | 1 BOTTLE in 1 CARTON (42582-900-06) / 180 mL in 1 BOTTLE |
| Marketing Start Date | 2011-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL dacbcc5a-d37c-4ea3-8f47-35abb64c7519 Details
DIRECTIONS
A liquid antiseborrehic, antifungal preparation for topical application.
Each mL of Selenium Sulfide 2.25% Shampoo contains 22.5 mg selenium sulfide, ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow #8, diazolidinyl urea, edetate disodium, FD&C red #40, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, sodium citrate, titanium dioxide, tocopheryl acetate, urea, zinc pyrithione.
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
CONTRAINDICATIONS
WARNINGS
PRECAUTIONS
This medication is to be used as directed by a physician. Not to be used when inflammation or exudation is present as increased absorption may occur.
CARCINOGENESIS
Dermal application of 25% and 50% solutions of 2.5% selenium sulfide lotion on mice over an 88-week period indicated no carcinogenic effects.
USE IN PREGNANCY
CATEGORY C
Animal reproduction studies have not been conducted with this medication. It is also not known whether this product can cause fetal harm when applied to the body surfaces of a pregnant woman or can affect reproduction capacity. Under ordinary circumstances, selenium sulfide 2.25% shampoo should not be used by pregnant women.
ADVERSE REACTIONS
OVERDOSAGE
There are no documented reports of serious toxicity in humans resulting from acute ingestion of selenium sulfide 2.25% shampoo. 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 USING
For seborrheic dermatitis and dandruff
Generally 2 applications each week for 2 weeks will control symptoms. Subsequently, shampoo may be used less frequently – weekly, every 2 weeks, every 3 to 4 weeks or as directed by a physician. Should not be applied more frequently than necessary to maintain control.
HOW SUPPLIED
Selenium Sulfide 2.25% Shampoo is supplied in 180 mL bottles, NDC 42582-900-06.
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). 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. Protect from freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| SELENIUM SULFIDE
selenium sulfide shampoo |
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| Labeler - Bi-Coastal Pharma International LLC (078397428) |
| Registrant - Bi-Coastal Pharma International LLC (078397428) |