Lidocaine HCl - Hydrocortisone Acetate
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
- Lidocaine HCl - Hydrocortisone Acetate
- Generic name
- LIDOCAINE HCL AND HYDROCORTISONE ACETATE
- Manufacturer
- PureTek Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- ac6c6117-97cc-4b7a-a831-03fb23a54b70
- SPL ID
- 2b4af474-aeb8-35c6-e063-6294a90ae7dd
- Version
- 3
- Effective date
- 2025-01-09
- Source export date
- 2026-09-28
- Source partition
- 10
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:07:27
| Harmonized routes |
|---|
| RECTAL |
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 |
|---|---|---|---|
| brand name | Lidocaine HCl - Hydrocortisone Acetate | openfda.brand_name | |
| generic name | LIDOCAINE HCL AND HYDROCORTISONE ACETATE | openfda.generic_name | |
| manufacturer name | PureTek Corporation | openfda.manufacturer_name | |
| ndc | package | 59088-816-01 | openfda.package_ndc |
| ndc | package | 59088-816-24 | openfda.package_ndc |
| ndc | product | 59088-816 | openfda.product_ndc |
| ndc11 | package | 59088081601 | derived:openfda.package_ndc |
| ndc11 | package | 59088081624 | derived:openfda.package_ndc |
| rxcui | 1012233 | openfda.rxcui | |
| spl id | 2b4af474-aeb8-35c6-e063-6294a90ae7dd | id | |
| spl set id | ac6c6117-97cc-4b7a-a831-03fb23a54b70 | set_id | |
| unii | 3X7931PO74 | openfda.unii | |
| unii | V13007Z41A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: For external use only. Not for ophthalmic use. Product and used applicators could harm small children if chewed or swallowed. Keep out of reach of children. Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes and abraded, fissured or irritated skin than through intact skin. Product should not be ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane into the middle ear is contraindicted because of ototoxicty associated with lidocaine observed in animals when instilled in the middle ear. Product should not come into contact with the eye or be applied into the eye because of the risk of severe eye irritation and the loss of eye surface sensation, which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water and protect the eye surface until sensation is restored.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: During or immediately following application of product, there may be transient stinging or burning from open areas of skin, or transient blanching (lightening), or erythema (redness) of the skin.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.