RENOVA® (TRETINOIN EMOLLIENT CREAM) 0.05%
FOR TOPICAL USE ON THE FACE ONLY
DESCRIPTION:
RENOVA (tretinoin emollient cream) 0.05% contains the active ingredient tretinoin (a retinoid) in an emollient cream base. Tretinoin is a yellow to light orange crystalline powder having a characteristic floral odor. Tretinoin is soluble in dimethylsulfoxide, slightly soluble in polyethylene glycol 400, octanol, and 100% ethanol. It is practically insoluble in water and mineral oil, and it is insoluble in glycerin. The chemical name for tretinoin is (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclonexen-1-yl)-2,4,6,8-nonatetraenoic acid. Tretinoin is also referred to as all- trans -retinoic acid and has a molecular weight of 300.44. The structural formula is represented below.
Tretinoin is available as RENOVA at a concentration of 0.05% w/w in a water in oil emulsion formulation consisting of light mineral oil, NF; sorbitol solution, USP; hydroxyoctacosanyl hydroxystearate; methoxy PEG-22/dodecyl glycol copolymer; PEG-45/dodecyl glycol copolymer; stearoxytrimethylsilane and stearyl alcohol; dimethicone 50 cs; methylparaben, NF; edetate disodium, USP; quaternium-15; butylated hydroxytoluene, NF; citric acid monohydrate, USP; fragrance; and purified water, USP.
|