Drug profile
Urea
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Apply Urea 40% to affected skin twice per day, or as directed by your physician.
Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per
day, or as directed by a physician. All prescription substitutions and/or
recommendations using this product shall be made subject to state and federal
statutes as applicable.
Source: US FDA label for urea (Urea Cream 40%), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- No child dose in this label. That usually means untested in children, not
unsuitable - use a paediatric source.
Source: Read and found silent: the US FDA label for urea (Urea Cream 40%),
retrieved 2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for urea (Urea Cream 40%),
retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for urea (Urea Cream 40%),
retrieved 2026-08-29
PREGNANCY
- Animal reproduction studies have revealed no evidence of harm to the fetus,
however, there are no adequate and well-controlled studies in pregnant women.
Source: US FDA label for urea (Urea Cream 40%), section 'pregnancy', retrieved
2026-08-29
- Because animal reproductive studies are not always predictive of human response,
Urea 40% should be given to a pregnant woman only if clearly needed.
Source: US FDA label for urea (Urea Cream 40%), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING [ CAUTION ]
The label allows it only when the benefit is judged to outweigh the risk. Read the
quote below.
- It is not known whether or not this drug is excreted in human milk.
Source: US FDA label for urea (Urea Cream 40%), section 'nursing mothers',
retrieved 2026-08-29
- Because many drugs are excreted in human milk, caution should be exercised when
Urea 40% is administered to a nursing woman.
Source: US FDA label for urea (Urea Cream 40%), section 'nursing mothers',
retrieved 2026-08-29