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

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - lidocaine hydrochloride anhydrous 30 mg in 1 g - product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. these products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically 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. safety and efficacy in children have not been established.

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

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - product is used for the anti-inflammatory and anesthetic relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures and similar conditions of the skin and mucous membranes. product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. this product is contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically 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. safety and efficacy in children have not been established.

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

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. these products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically 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. safety and efficacy in children have not been established.

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

seton pharmaceuticals - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area. product should not be used in patients with a history of sensitivity to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually do not cross-react with “caine” ester type anesthetics. if excessive irritation and significant worsening occur, discontinue use and seek the advice of your physician. product and topical lidocaine should be used cautiously in those with impaired liver function, as well as the very ill or very elderly and those with significant liver disease. product should be used with caution on patients receiving antiarrhythmic drugs of class i since the adverse effects are additive and generally synergistic. these products are contraindicated for tuberculous or fungal lesions or skin vaccinia, varicella and acute herpes simplex. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. pregnancy category c. reproduction studies have been performed for lidocaine in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. there are, however, no adequate and well-controlled studies in pregnant women. animal reproduction studies are not always predictive of human response. general consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place. corticosteroids are generally teratogenic in laboratory animals when administered systemically 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. safety and efficacy in children have not been established.

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

taro pharmaceuticals u.s.a., inc. - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - anti-itch cream - temporary relief of itching associated with minor skin irritations and rashes due to eczema insect bites poison ivy, poison oak, or poison sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis external genital and anal itching - eczema - insect bites - poison ivy, poison oak, or poison sumac - soaps - detergents - cosmetics - jewelry - seborrheic dermatitis - psoriasis - external genital and anal itching - other uses of this product should be only under the advice and supervision of a doctor

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

kmm pharmaceuticals, llc - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj), iodoquinol (unii: 63w7ie88k8) (iodoquinol - unii:63w7ie88k8) - based on a review of a related drug by the national research council and subsequent fda classification for that drug, the indications are as follows: “possibly” effective: contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. final classification of the less-than-effective indications requires further investigation. this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

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

pharmaceutical specialties, inc. - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate 1.12 g in 100 g - purpose anti-itch uses - for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: · eczema · psoriasis · insect bites · detergents · jewelry · seborrheic dermatitis · soaps · cosmetics · poison ivy, oak, sumac - for the temporary relief of external genital and anal itching - other uses of this product should be only under the advice and supervision of a doctor do not use - in the genital area if you have a vaginal discharge. consult a doctor. - for the treatment of diaper rash. consult a doctor. stop use and ask a doctor if - condition worsens - rectal bleeding occurs - symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

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

paddock laboratories, llc - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients with a history of hypersensitivity to any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

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

proficient rx lp - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of anorectum, and pruritus ani. hydrocortisone acetate suppositories are contraindicated in those patients having a history of hypersensitivity to hydrocortisone acetate or any of the components. drug abuse and dependence have not been reported in patients treated with hydrocortisone acetate suppositories.

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

acella pharmaceuticals, llc - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate 25 mg in 1 g