United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

karo pharma uk ltd - cutaneous cream

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

leo pharma a/s denmark, denmark - hydrocortisone butyrate - cream - 0.1 %

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

astellas pharma - hydrocortisone butyrate - cream - 0.1 %

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

cheplapharm arzneimittel gmbh, germany - hydrocortisone butyrate - cream - 0.1 %

Canada - English - Health Canada

organon canada inc. - mometasone furoate - cream - 0.1% - mometasone furoate 0.1% - anti-inflammatory agents

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate 1 mg in 1 g - hydrocortisone butyrate cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. none.

Malta - English - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - hydrocortisone butyrate - cutaneous emulsion - hydrocortisone butyrate 1 mg/g - corticosteroids, dermatological preparations

United States - English - NLM (National Library of Medicine)

oceanside pharmaceuticals - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate cream (lipid), 0.1% is indicated for: none. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, hydrocortisone butyrate cream (lipid), 0.1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. note: the animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (mthd) for hydrocortisone butyrate cream (25 g). systemic embryofetal development studies were conducted in rats and rabbits. subcutaneous doses of 0.6, 1.8, and 5.4 mg/kg/day hydrocortisone butyrate were administered to preg

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - hydrocortisone butyrate 0.1%;   - topical cream - 0.1 % - active: hydrocortisone butyrate 0.1%   excipient: butyl hydroxybenzoate cetomacrogol 1000 cetostearyl alcohol citric acid light liquid paraffin propyl hydroxybenzoate purified water sodium citrate white soft paraffin

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - chlorquinaldol 3%; hydrocortisone butyrate 0.1%;   - topical cream - 3%/0.1% - active: chlorquinaldol 3% hydrocortisone butyrate 0.1%