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

pharmaderm a division of fougera pharmaceuticals inc. - doxepin hydrochloride (unii: 3u9a0fe9n5) (doxepin - unii:5asj6huz7d) - doxepin hydrochloride 50 mg in 1 g

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

pharmaderm a division of fougera pharmaceuticals inc. - hydrocortisone probutate (unii: o6550d6k3a) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone probutate 1 mg in 1 g - pandel® (hydrocortisone probutate) cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 18 years of age or older. none. risk summary there is no clinical information on pandel use in pregnant women to inform any drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, hydrocortisone probutate given by the subcutaneous route during the period of organogenesis was teratogenic at doses equal to or greater than 1 mg/kg/day in rats or 0.1 mg/kg/day in rabbits (12 times and 2 times the human topical dose, respectively) [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, res

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

pharmaderm a division of fougera pharmaceuticals inc. - terconazole (unii: 0kj2ve664u) (terconazole - unii:0kj2ve664u) - terconazole 4 mg in 1 g

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

pharmaderm a division of fougera pharmaceuticals inc. - terconazole (unii: 0kj2ve664u) (terconazole - unii:0kj2ve664u) - terconazole 80 mg

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

pharmaderm a division of fougera pharmaceuticals inc. - methscopolamine bromide (unii: rtn51lk7wl) (methscopolamine - unii:vdr09vtq8u) - methscopolamine bromide 2.5 mg - adjunctive therapy for the treatment of peptic ulcer. methscopolamine bromide has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence or preventing complications. glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. pamine® 2.5 mg/pamine® forte 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs. not applicable.

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

pharmaderm a division of fougera pharmaceuticals inc. - lactobacillus acidophilus (unii: 1prr1v42v5) (lactobacillus acidophilus - unii:1prr1v42v5) - lactobacillus acidophilus 16000000000 [cfu]

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

pharmaderm a division of fougera pharmaceuticals inc. - lactobacillus acidophilus (unii: 1prr1v42v5) (lactobacillus acidophilus - unii:1prr1v42v5) - lactobacillus acidophilus 8000000000 [cfu]

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

pharmaderm, a division of fougera pharmaceuticals inc. - tavaborole (unii: k124a4euq3) (tavaborole - unii:k124a4euq3) - kerydin (tavaborole) topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to trichophyton rubrum or trichophyton mentagrophytes . none. risk summary there are no available data on kerydin use in pregnant women to inform a drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofetal toxicity and malformations at 570 times the maximum recommended human dose (mrhd) based on area under the curve (auc) comparisons in rats and embryofetal toxicity at 155 times the mrhd based on auc comparisons in rabbits. embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the mrhd based on auc comparisons [see data ]. the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or oth

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

pharmaderm, a division of fougera pharmaceuticals inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37) - sodium chloride 30 mg in 1 ml - moisturizer uses: - wash away allergens, dust, dirt & pollens - increse ciliary flow - improve breathing - clear congestion - help reduce nasal swelling

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

pharmaderm a division of fougera pharmaceuticals inc. - sinecatechins (unii: t432289gyz) (sinecatechins - unii:t432289gyz) - sinecatechins 150 mg in 1 g - veregen® is indicated for the topical treatment of external genital and perianal warts (condylomata acuminata) in immunocompetent patients 18 years and older. the safety and effectiveness of veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses. the safety and effectiveness of veregen® in immunosuppressed patients have not been established. none risk summary there are no available data on veregen use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, sinecatechins did not cause malformations, but did affect the developing fetus in the presence of maternal toxicity when given to pregnant rabbits and rats by intravaginal or systemic routes of administration during the period of organogenesis (see data ). the available data do not allow the calculation of relevant comparisons between the systemic exposure of sinecatechins observed in the animal studie