FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Capex Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Capex® Shampoo is a low to medium potency corticosteroid indicated for the treatment of seborrheic dermatitis of the scalp. This product has not been proven to be effective in other corticosteroid-responsive dermatoses.
History
There is currently no drug history available for this drug.
Other Information
Capex® Shampoo 0.01% is supplied as a shampoo formulation with a 12 mg fluocinolone acetonide capsule which is emptied into the shampoo base by the pharmacist at the time of dispensing. After mixing, Capex® Shampoo contains fluocinolone acetonide(6α,9-Difluoro-11β,16α, 17,21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16,17-acetal with acetone), a synthetic fluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as an anti-inflammatory and antipruritic agents.
Chemically, Capex® Shampoo mixture is C24H30F2O6. It has the following structural formula:
Fluocinolone acetonide in Capex® Shampoo has the molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light and melts at 270°F with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each fluocinolone capsule contains 12 mg of fluocinolone acetonide, 548 mg of dibasic calcium phosphate dihydrate USP, and 240 mg of talc USP. The shampoo base contains aluminum acetate basic, benzalkonium chloride solution, boric acid, citric acid anhydrous, cocamido-ether-sulfate complex, cocoamine oxide, lauramide DEA, magnesium aluminum silicate, methylparaben, oat flour, propylene glycol, propylparaben, purified water, and fragrances, with D&C Yellow #10 and FD&C Blue #1 as coloring.
Sources
Capex Manufacturers
-
Galderma Laboratories, L.p.
Capex | Galderma Laboratories, L.p.
The pharmacist must empty the contents of the enclosed capsule into the shampoo base prior to dispensing to the patient. This product should be shaken well prior to use. No more than approximately one (1) ounce of the medicated shampoo should be applied to the scalp area once daily, worked into a lather and allowed to remain on the scalp for approximately 5 minutes. The hair and scalp should then be rinsed thoroughly with water.
Login To Your Free Account