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
- 85291b2b-40b9-07fa-e053-2a91aa0a84e4
- SPL ID
- 42c769de-f1e0-b3a1-e063-6394a90ab2a1
- Version
- 10
- Effective date
- 2025-11-04
- Source export date
- 2026-10-12
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:12:26
| 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 | 54365-400-31 | openfda.package_ndc |
| ndc | product | 54365-400 | openfda.product_ndc |
| ndc11 | package | 54365040031 | derived:openfda.package_ndc |
| rxcui | 858726 | openfda.rxcui | |
| rxcui | 998282 | openfda.rxcui | |
| spl id | 42c769de-f1e0-b3a1-e063-6394a90ab2a1 | id | |
| spl set id | 85291b2b-40b9-07fa-e053-2a91aa0a84e4 | 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.