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

binger consulting corporation - allantoin (unii: 344s277g0z) (allantoin - unii:344s277g0z), petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - skin protectant skin protectant • scar management • temporarily protects minor cuts, scrapes and burns

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

binger consulting corporation - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987), menthol, unspecified form (unii: l7t10eip3a) (menthol - unii:l7t10eip3a) - topical analgesic external analgesic • temporary relief of pain associated with minor cuts, scrapes, and minor skin irritations

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

binger consulting corporation - menthol, unspecified form (unii: l7t10eip3a) (menthol - unii:l7t10eip3a) - analgesic/counterirritant • temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness

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

preferred pharmaceuticals inc. - docusate sodium (unii: f05q2t2ja0) (docusate - unii:m7p27195ag) - stool softener

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

bryant ranch prepack - mupirocin calcium (unii: rg38i2p540) (mupirocin - unii:d0gx863oa5) - mupirocin cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of staphylococcus aureus (s. aureus) and streptococcus pyogenes (s. pyogenes). mupirocin cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin cream. risk summary there are insufficient human data to establish whether there is a drug-associated risk with mupirocin cream in pregnant women. systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin cream [see clinical pharmacology (12.3)] . no developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. the estimated background risk in the u.s. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data: developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. this dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. in rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. there was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area. mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. this dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. the no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose. risk summary it is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. however, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of mupirocin cream [see clinical pharmacology (12.3)] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mupirocin cream and any potential adverse effects on the breastfed child from mupirocin cream or from the underlying maternal condition. clinical considerations to minimize oral exposure of the drug to children, a breast and/or nipple being treated with mupirocin cream should be thoroughly washed prior to breastfeeding. the safety and effectiveness of mupirocin cream have been established in the age-groups 3 months to 16 years. use of mupirocin cream in these age-groups is supported by evidence from adequate and well-controlled trials of mupirocin cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see clinical studies (14)] . in 2 adequate and well-controlled trials, 30 subjects older than 65 years were treated with mupirocin cream. no overall difference in the efficacy or safety of mupirocin cream was observed in this patient population when compared with that observed in younger patients.

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

rite aid corporation - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 160 mg - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold - headache - sore throat - flu - toothache - the common cold - temporarily reduces fever

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

walgreen company - acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - pain reliever/fever reducer - temporarily relieves minor aches and pains due to: headache sore throat flu toothache the common cold - headache - sore throat - flu - toothache - the common cold - temporarily reduces fever

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

skin sake, llc - zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z) - skin protectant - helps soothe, treat , and prevent diaper rash - repels wetness - protects delicate skin - relieves chapped, moist or irritated areas - prevents friction

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

nucare pharmaceuticals,inc. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid capsules are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid capsules are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precautions (5.1) for statement regarding fatal hepatic dysfunction. because of the risk to the fetus of decreased iq, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women wit

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

axichem pty ltd - dicamba present as the dimethylamine salt - soluble concentrate - dicamba present as the dimethylamine salt benzoic acid-arylaliphatic active 500.0 g/l - herbicide