warnings
Warnings For external use only. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days.
DERMATITIS FACE BALM
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
- DERMATITIS FACE BALM
- Generic name
- COLLOIDAL OATMEAL
- Manufacturer
- Skinfix, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6
- SPL ID
- 47ebdead-4009-888b-e063-6394a90a1362
- Version
- 7
- Effective date
- 2026-01-08
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:18:57
| 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 number | M016 | openfda.application_number | |
| brand name | DERMATITIS FACE BALM | openfda.brand_name | |
| generic name | COLLOIDAL OATMEAL | openfda.generic_name | |
| manufacturer name | Skinfix, Inc. | openfda.manufacturer_name | |
| ndc | package | 61328-121-12 | openfda.package_ndc |
| ndc | product | 61328-121 | openfda.product_ndc |
| ndc11 | package | 61328012112 | derived:openfda.package_ndc |
| rxcui | 1738987 | openfda.rxcui | |
| spl id | 47ebdead-4009-888b-e063-6394a90a1362 | id | |
| spl set id | 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 | set_id | |
| unii | 8PI54V663Y | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.