RENOVA- tretinoin cream

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Tretinoin (UNII: 5688UTC01R) (Tretinoin - UNII:5688UTC01R)

Disponibil de la:

Bausch Health US LLC

INN (nume internaţional):

Tretinoin

Compoziție:

Tretinoin 0.2 mg in 1 g

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin crea

Rezumat produs:

RENOVA® (tretinoin cream), 0.02% is available in tubes containing 20 grams (NDC 0187-5150-20), 40 grams (NDC 0187-5150-40), 60 grams (NDC 0187-5150-60), and in pumps containing 44 grams (NDC 0187-5150-44). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

RENOVA- TRETINOIN CREAM
BAUSCH HEALTH US LLC
----------
RENOVA
(TRETINOIN CREAM)
0.02%
FOR TOPICAL USE ON THE FACE. NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE.
DESCRIPTION
RENOVA (tretinoin cream) 0.02% contains the active ingredient
tretinoin in a 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-cyclohexen-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 0.02% w/w in an
oil-in-water emulsion
formulation consisting of benzyl alcohol, butylated hydroxytoluene,
caprylic/capric triglyceride, cetyl
alcohol, edetate disodium, methylparaben, propylparaben, purified
water, stearic acid, stearyl alcohol,
steareth 2, steareth 20, and xanthan gum.
CLINICAL PHARMACOLOGY
Tretinoin is an endogenous retinoid metabolite of Vitamin A that binds
to intracellular receptors in the
cytosol and nucleus, but cutaneous levels of tretinoin in excess of
physiologic concentrations occur
following application of a tretinoin-containing topical drug product.
Although tretinoin activates three
members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ,
and RARγ) which may act to
modify gene expression, subsequent protein synthesis, and epithelial
cell growth and differentiation, it
has not been established whether the clinical effects of tretinoin are
mediated through activation of
retinoic acid receptors, other mechanisms such as irritation, or both.
The effect of tretinoin on skin with chronic photodamage has not been
evaluated in animal studies. When
hairless albino mice were treated topically with tretinoin shortly
afte