warnings
WARNING Sun exposure to areas of the skin treated with Lac-Hydrin Cream should be minimized or avoided (see PRECAUTIONS section).The use of Lac-Hydrin Cream should be discontinued if any hypersensitivity is observed.
FDA label 807054c6-2dae-4cc2-b790-674ab66cf79b
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 807054c6-2dae-4cc2-b790-674ab66cf79b
- SPL ID
- 807054c6-2dae-4cc2-b790-674ab66cf79b
- Version
- 1
- Effective date
- 2009-09-25
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:21:04
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 807054c6-2dae-4cc2-b790-674ab66cf79b | id | |
| spl set id | 807054c6-2dae-4cc2-b790-674ab66cf79b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In controlled clinical trials of patients with ichthyosis vulgaris, the most frequent adverse reactions in patients treated with Lac-Hydrin Cream were rash (including erythema and irritation) and burning/stinging. Each was reported in approximately 10-15% of patients. In addition, itching was reported in approximately 5% of patients. In controlled clinical trials of patients with xerosis, the most frequent adverse reactions in patients treated with Lac-Hydrin Cream were transient burning, in about 3% of patients, stinging, dry skin and rash, each reported in approximately 2% of patients.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.