warnings
WARNINGS Sun exposure to areas of the skin treated with Ammonium Lactate Lotion, 12% should be minimized or avoided (see PRECAUTIONS section). The use of Ammonium Lactate Lotion should be discontinued if hypersensitivity is observed.
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
- Sun Pharmaceutical Industries, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 8bb09bb3-5bbc-489d-96c1-ae97cb58381e
- SPL ID
- 57d7e3ba-2c3e-a79b-e063-6394a90a4a5b
- Version
- 7
- Effective date
- 2026-07-30
- Source export date
- 2026-10-30
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-30/9abf0f8b126f8aad070e21ea702bfb5e39ce670b16ae57dd52e8877705d1bf5d/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
- Import run
- 20261102T182004Z
- Imported at
- 2026-11-02 19:30:42
| 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 | 076216 | derived:openfda.application_number |
| application number | ANDA076216 | openfda.application_number | |
| brand name | Ammonium Lactate | openfda.brand_name | |
| generic name | AMMONIUM LACTATE | openfda.generic_name | |
| manufacturer name | Sun Pharmaceutical Industries, Inc. | openfda.manufacturer_name | |
| ndc | package | 51672-1300-5 | openfda.package_ndc |
| ndc | package | 51672-1300-9 | openfda.package_ndc |
| ndc | product | 51672-1300 | openfda.product_ndc |
| ndc11 | package | 51672130009 | derived:openfda.package_ndc |
| ndc11 | package | 51672130005 | derived:openfda.package_ndc |
| rxcui | 197362 | openfda.rxcui | |
| spl id | 57d7e3ba-2c3e-a79b-e063-6394a90a4a5b | id | |
| spl set id | 8bb09bb3-5bbc-489d-96c1-ae97cb58381e | 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 The most frequent adverse experiences in patients with xerosis are transient stinging (1 in 30 patients), burning (1 in 30 patients), erythema (1 in 50 patients) and peeling (1 in 60 patients). Other adverse reactions which occur less frequently are irritation, eczema, petechiae, dryness and hyperpigmentation. Due to the more severe initial skin conditions associated with ichthyosis, there was a higher incidence of transient stinging, burning and erythema (each occurring in 1 in 10 patients). To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.