Label: SELENIUM SULFIDE shampoo
- NDC Code(s): 63629-2002-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 42494-336
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated July 1, 2021
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- FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
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:
PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
Avoid contact with eyes, lips and mucous membranes.
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.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
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.
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:
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
INGREDIENTS AND APPEARANCE
selenium sulfide shampoo
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2002(NDC:42494-336) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE 23 mg in 1 mL Inactive Ingredients Ingredient Name Strength AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) TRICAPRIN (UNII: O1PB8EU98M) CHROMIC OXIDE (UNII: X5Z09SU859) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) FLUORESCEIN SODIUM (UNII: 93X55PE38X) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI) EDETATE DISODIUM (UNII: 7FLD91C86K) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) PANTHENOL (UNII: WV9CM0O67Z) PPG-2 HYDROXYETHYL COCO/ISOSTEARAMIDE (UNII: EK4J71ZKEQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) UREA (UNII: 8W8T17847W) PYRITHIONE ZINC (UNII: R953O2RHZ5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-2002-1 180 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/20/2018 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-2002) , RELABEL(63629-2002)