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ventura corporation ltd - octinoxate: 7.00% - sunscreen - helps prevent sunburn.

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ventura international ltd - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - octinoxate 0.075 g in 1 ml - - helps prevent sunburn.

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

ventura corporation ltd - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - octinoxate 0.075 g in 1 ml - - helps prevent sunburn.

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

ventura corporation ltd - octinoxate (unii: 4y5p7mud51) (octinoxate - unii:4y5p7mud51), oxybenzone (unii: 95oos7ve0y) (oxybenzone - unii:95oos7ve0y) - octinoxate 0.047 g in 1 g - - helps prevent sunburn.

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

pure source, llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - zinc oxide 95 mg in 1 ml - - helps prevent sunburn - if used as directed with other sun protection measures (see directions), sunscreen decreases the risk of skin cancer and early skin aging caused by the sun.

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accord healthcare, inc. - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 15 mg - monotherapy and combination therapy pioglitazone tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablet exerts its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. risk summary limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, no adverse developmental effects were observed when pioglitazone was administered to pregnant rats and rabbits during organogenesis at exposures up to 5-and 35-times the 45 mg clinical dose, respectively, based on body surface area [see data] . the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20 to 25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. 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%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, still birth and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data pioglitazone administered to pregnant rats during organogenesis did not cause adverse developmental effects at a dose of 20 mg/kg (~5-times the 45 mg clinical dose), but delayed parturition and reduced embryofetal viability at 40 and 80 mg/kg, or ≥9-times the 45 mg clinical dose, by body surface area. in pregnant rabbits administered pioglitazone during organogenesis, no adverse developmental effects were observed at 80 mg/kg (~35-times the 45 mg clinical dose), but reduced embryofetal viability at 160 mg/kg, or ~69-times the 45 mg clinical dose, by body surface area. when pregnant rats received pioglitazone during late gestation and lactation, delayed postnatal development, attributed to decreased body weight, occurred in offspring at maternal doses of 10 mg/kg and above or ≥2 times the 45 mg clinical dose, by body surface area. risk summary there is no information regarding the presence of pioglitazone in human milk, the effects on the breastfed infant, or the effects on milk production. pioglitazone is present in rat milk; however due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pioglitazone hydrochloride and any potential adverse effects on the breastfed infant from pioglitazone hydrochloride or from the underlying maternal condition. discuss the potential for unintended pregnancy with premenopausal women as therapy with pioglitazone hydrochloride, like other thiazolidinediones, may result in ovulation in some anovulatory women. safety and effectiveness of pioglitazone hydrochloride in pediatric patients have not been established. pioglitazone hydrochloride is not recommended for use in pediatric patients based on adverse effects observed in adults, including fluid retention and congestive heart failure, fractures, and urinary bladder tumors [see warnings and precautions ( 5.1, 5.4, 5.5 and 5.6)]. a total of 92 patients (15.2%) treated with pioglitazone hydrochloride in the three pooled 16- to 26-week double-blind, placebo-controlled, monotherapy trials were ≥65 years old and two patients (0.3%) were ≥75 years old. in the two pooled 16- to 24-week add-on to sulfonylurea trials, 201 patients (18.7 %) treated with pioglitazone hydrochloride were ≥65 years old and 19 (1.8%) were ≥75 years old. in the two pooled 16- to 24-week add-on to metformin trials, 155 patients (15.5%) treated with pioglitazone hydrochloride were ≥65 years old and 19 (1.9%) were ≥75 years old. in the two pooled 16- to 24-week add-on to insulin trials, 272 patients (25.4%) treated with pioglitazone hydrochloride were ≥65 years old and 22 (2.1%) were ≥75 years old. in proactive, 1068 patients (41.0%) treated with pioglitazone hydrochloride were ≥65 years old and 42 (1.6%) were ≥75 years old. in pharmacokinetic studies with pioglitazone, no significant differences were observed in pharmacokinetic parameters between elderly and younger patients [see clinical pharmacology (12.3)] . although clinical experiences have not identified differences in effectiveness and safety between the elderly (≥ 65 years) and younger patients, these conclusions are limited by small sample sizes for patients ≥75 years old.

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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.

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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.

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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

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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