warnings
WARNING Sun exposure to areas of the skin treated with Ammonium Lactate Cream, 12% should be minimized or avoided (see PRECAUTIONS ). Use of this product should be discontinued if hypersensitivity to any of the ingredients is noted.
Ammonium Lactate
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
- Brand name
- Ammonium Lactate
- Generic name
- AMMONIUM LACTATE
- Manufacturer
- Bryant Ranch Prepack
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 2455f1aa-562d-424a-9542-4853adf1ca75
- SPL ID
- 00b2bf41-a961-6394-e063-6394a90ac8fc
- Version
- 103
- Effective date
- 2023-07-17
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:35:38
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| application applno | ANDA | 075774 | derived:openfda.application_number |
| application number | ANDA075774 | openfda.application_number | |
| brand name | Ammonium Lactate | openfda.brand_name | |
| generic name | AMMONIUM LACTATE | openfda.generic_name | |
| manufacturer name | Bryant Ranch Prepack | openfda.manufacturer_name | |
| ndc | package | 63629-8609-1 | openfda.package_ndc |
| ndc | product | 63629-8609 | openfda.product_ndc |
| ndc11 | package | 63629860901 | derived:openfda.package_ndc |
| rxcui | 543460 | openfda.rxcui | |
| spl id | 00b2bf41-a961-6394-e063-6394a90ac8fc | id | |
| spl set id | 2455f1aa-562d-424a-9542-4853adf1ca75 | set_id | |
| unii | 67M901L9NQ | openfda.unii |
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 ammonium lactate 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 ammonium lactate 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.