HC Pram Cream

River’s Edge HC Pram 2.5% Cream – 2.5% Hydrocortisone Acetate, 1% Pramoxine HCl
Contains hydrocortisone acetate 25mg w/w and pramoxine hydrochloride 10mg
ACTIVE INGREDIENTS:
HYDROCORTISONE ACETATE 2.5%
PRAMOXINE HCl 1%
INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

River’s Edge HC Pram 1% Cream – 1% Hydrocortisone Acetate, 1% Pramoxine HCl
Contains hydrocortisone acetate 10mg w/w and pramoxine hydrochloride 10mg
ACTIVE INGREDIENTS:
HYDROCORTISONE ACETATE 1%
PRAMOXINE HCl 1%
INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20, CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinicl efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydro-cortisone have revealed negative results.

Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systematically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Applies to hydrocortisone / pramoxine topical: external cream, external foam, external gel, external lotion, external ointment

Other dosage forms:

• rectal cream, rectal foam, rectal kit, rectal lotion