warnings
Warnings For external use only. Flammable, keep away from fire or flame. • do not use with electrocautery procedures
ChloraPrep One-Step
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
- ChloraPrep One-Step
- Generic name
- CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
- Manufacturer
- CareFusion 213, LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 8528a4f5-5ff4-45f3-e053-2991aa0a804c
- SPL ID
- 42b9d7a7-e6ae-d2ec-e063-6394a90aed91
- Version
- 10
- Effective date
- 2025-11-03
- Source export date
- 2026-09-28
- 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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:16:46
| 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 | NDA | 020832 | derived:openfda.application_number |
| application number | NDA020832 | openfda.application_number | |
| brand name | ChloraPrep One-Step | openfda.brand_name | |
| generic name | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL | openfda.generic_name | |
| manufacturer name | CareFusion 213, LLC | openfda.manufacturer_name | |
| ndc | package | 54365-400-30 | openfda.package_ndc |
| ndc | product | 54365-400 | openfda.product_ndc |
| ndc11 | package | 54365040030 | derived:openfda.package_ndc |
| rxcui | 858726 | openfda.rxcui | |
| rxcui | 998282 | openfda.rxcui | |
| spl id | 42b9d7a7-e6ae-d2ec-e063-6394a90aed91 | id | |
| spl set id | 8528a4f5-5ff4-45f3-e053-2991aa0a804c | set_id | |
| unii | MOR84MUD8E | openfda.unii | |
| unii | ND2M416302 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: • wheezing/difficulty breathing • shock • facial swelling • hives • rash If an allergic reaction occurs, stop use and seek medical help right away.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.