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 3cdeea78-94fd-449e-8286-ab3484905233
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
- cae7a7d5-f4f4-41da-a71f-d542322ce267
- SPL ID
- 3cdeea78-94fd-449e-8286-ab3484905233
- Version
- 2
- Effective date
- 2013-09-27
- Source export date
- 2026-09-28
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:17:16
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 | 3cdeea78-94fd-449e-8286-ab3484905233 | id | |
| spl set id | cae7a7d5-f4f4-41da-a71f-d542322ce267 | 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.