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NDC 42494-0336-06 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 Cameron 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: 42494-0336-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Selenium Sulfide
Product Information
| NDC | 42494-0336 |
|---|---|
| Product ID | 42494-336_15f869cc-a2f8-41f7-9a9d-8ff48cf0bb75 |
| 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 | Cameron Pharmaceuticals, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 42494-0336-06 (42494033606)
| NDC Package Code | 42494-336-06 |
|---|---|
| Billing NDC | 42494033606 |
| Package | 180 mL in 1 BOTTLE (42494-336-06) |
| Marketing Start Date | 2018-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4414584a-d706-4164-a33a-e1b3bfacc9cf Details
DESCRIPTION:
Each mL contains 23 mg of selenium sulfide in a vehicle consisting of: ammonium lauryl sulfate, caprylic/capric triglyceride, chromium oxide green, citric acid, cocamidopropyl betaine, D&C yellow no 8, diazolidinyl urea, distearyl phthalic acid amide, edetate disodium, fragrance, hydroxypropyl methylcellulose, magnesium aluminum silicate, methylparaben, panthenol, PPG-2 hydroxyethyl coco/isostearamide, propylene glycol, propylparaben, purified water, FD&C red no 40, sodium citrate, titanium dioxide, tocopheryl acetate, urea, and zinc pyrithione.
CLINICAL PHARMACOLOGY:
INDICATIONS:
CONTRAINDICATIONS:
WARNINGS:
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Avoid contact with eyes, lips and mucous membranes.
General:
Selenium Sulfide 2.3% Shampoo is to be used as directed by a licensed medical practitioner 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 licensed medical practitioner.
Information for Patients:
Patients should discontinue the use of Selenium Sulfide 2.3% Shampoo 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.
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:
In decreasing order of severity: skin irritation; occasional reports of increase in normal hair loss; discoloration of hair (can be avoided or minimized by thorough rinsing of hair after treatment). As with other shampoos, oiliness or dryness of hair and scalp may occur.
Call your licensed medical practitioner for medical advice about side effects. To report a serious adverse event, call 1-888-767-7913.
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:
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 licensed medical practitioner. 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 licensed medical practitioner.
HOW SUPPLIED:
STORAGE:
Store at 20-25°C (68-77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.
Protect from freezing and excessive heat. Keep bottle tightly closed.
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product has not been evaluated for therapeutic equivalence.
SPL UNCLASSIFIED SECTION
Principal Display Panel - 180 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| SELENIUM SULFIDE
selenium sulfide shampoo |
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| Labeler - Cameron Pharmaceuticals, LLC (078371442) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cameron Pharmaceuticals, Limited Liability Company | 078371442 | MANUFACTURE(42494-336) | |