Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

ventura corporation ltd - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - octinoxate 0.05 g in 1 ml - - helps prevent sunburn. - if used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

takeda pharmaceuticals america, inc. - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum cation (3+) 500 mg - fosrenol is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (esrd). management of elevated serum phosphorus levels in patients with esrd usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. contraindicated in bowel obstruction, including ileus and fecal impaction. risk summary available data from case reports with use of fosrenol in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (mrhd), resulted in no adverse developmental effects. in rabbits, lanthanum carbonate doses 5 times the mrhd was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see data) . deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a pregnant woman. 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 defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus. the mrhd for fosrenol is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m2 for a 60-kg patient. the 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m2 , 3 times the mrhd. in pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m2 ; 5 times the daily mrhd) during organogenesis was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. no effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m2 ; 2.5 times the mrhd). in a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m2 /day; equivalent to 3 times the mrhd) from day 6 of pregnancy through 20 days postpartum (including lactation). at 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day. at 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the mrhd, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see nonclinical toxicology (13.2)] . risk summary there are no data on the presence of lanthanum carbonate from fosrenol in human milk, the effects on the breastfed infant, or the effects on milk production. deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a lactating woman. the safety and efficacy of fosrenol in pediatric patients have not been established. while growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. the consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of fosrenol in this population is not recommended. of the total number of patients in clinical studies of fosrenol, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. no overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

science of skincare llc - zinc oxide – 4.20% octinoxate – 3.30% - sunscreen • helps hydrate and prevent sunburn. • if used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun • do not use on damaged or broken skin • stop use and ask a doctor if rash occurs

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

it3 medical llc - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine injection, and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration , and adverse reactions ). patients should be switched to alternative analgesics a

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lifetech resources, llc - octinoxate 7.5%, avobenzone 2.0% - sunscreen helps prevent sunburn. higher spf gives more sunburn protection.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

the soleil group, llc - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - helps prevent sunburn. if used as directed with other sun protection measures (see directions: ), decreases the risk of skin cancer and early skin aging caused by the sun. sunscreen

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

jsb4, llc - zinc oxide 10.1%, sunscreen - - helps prevent sunburn - if used as directed with other sun protection measures ( see directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

edgewell personal care brands llc - avobenzone 1.5%, octisalate 3%, octocrylene 2% - sunscreen helps prevent sunburn on damaged or broken skin if rash occurs

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

the procter & gamble manufacturing company - avobenzone (unii: g63qqf2nox) (avobenzone - unii:g63qqf2nox), homosalate (unii: v06sv4m95s) (homosalate - unii:v06sv4m95s), octisalate (unii: 4x49y0596w) (octisalate - unii:4x49y0596w), octocrylene (unii: 5a68wgf6wm) (octocrylene - unii:5a68wgf6wm) - - helps prevent sunburn - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

jsb4, llc - zinc oxide (unii: soi2loh54z) (zinc cation - unii:13s1s8sf37) - - helps prevent sunburn - if used as directed with other sun protection measures ( ​see directions ​), decreases the risk of skin cancer and early skin agin caused by the sun.