Selenos Shampoo
Name: Selenos Shampoo
Contraindications
Contraindicated in persons with known or suspected hypersensitivity to any of the listed ingredients.
Pediatric Use
Safety and effectiveness in children have not been established.
How supplied
Selenos™ Shampoo (Selenium Sulfide 2.25%) is supplied in 180 ml bottles, NDC 51991-472-68.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°F-86°F). See USP Controlled Room Temperature. Protect from freezing.
Warning: Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately.
Do not accept if plastic safety shell has been removed or broken.
All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Manufactured by: Harmony Labs, Inc., Landis, NC 28088
Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487
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SELENOS
selenium sulfide shampoo, suspension |
| Product Information | | Product Type | HUMAN PRESCRIPTION DRUG LABEL | Item Code (Source) | NDC:51991-472 | | Route of Administration | TOPICAL | DEA Schedule | | |
| Active Ingredient/Active Moiety | | Ingredient Name | Basis of Strength | Strength | | Selenium Sulfide (Selenium) | Selenium Sulfide | 0.0225 mg in 1 mL | |
| Inactive Ingredients | | Ingredient Name | Strength | | urea | | | pyrithione zinc | | | water | | | edetate disodium | | | propylene glycol | | | diazolidinyl urea | | | methylparaben | | | propylparaben | | | ammonium lauryl sulfate | | | titanium dioxide | | | medium-chain triglycerides | | | D&C yellow no. 8 | | | FD&C red no. 40 | | | chromic oxide | | | citric acid monohydrate | | | sodium citrate | | | cocamidopropyl betaine | | | lauric diethanolamide | | | magnesium aluminum silicate | | | hypromelloses | | |
| Product Characteristics | | Color | ORANGE (dark orange) | Score | | | Shape | | Size | | | Flavor | | Imprint Code | | | Contains | | |
| Packaging | | # | Item Code | Package Description | | 1 | NDC:51991-472-68 | 180 mL in 1 BOTTLE | |
|
| Marketing Information | | Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date | | Unapproved Drug Other | | 01/01/2007 | 09/30/2011 | |
| Labeler - Breckenridge Pharmaceutical, Inc. (150554335) |
| Registrant - Harmony Labs, Inc. (105803274) |
| Establishment |
| Name | Address | ID/FEI | Operations |
| Harmony Labs, Inc. | | 105803274 | MANUFACTURE |
Revised: 12/2010 Breckenridge Pharmaceutical, Inc.
