FDA.reportPublic FDA data

ASEPSO ANTISEPTIC ORIGINAL

Manufacturer
CODAA Switzerland AG
Effective date
2023-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:46

Label at a glance#

ProductASEPSO ANTISEPTIC ORIGINAL
Active ingredientCHLOROXYLENOL
Label structure7 sections

Dosage and administration

Wet hands and forearms. Apply to hands and forearms. Scrub thoroughly for 60 seconds. Rinse and repeat.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.25%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop.
  • condition persists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands and forearms.
  • Apply to hands and forearms. Scrub thoroughly for 60 seconds.
  • Rinse and repeat.

Other information

SPL UNCLASSIFIED SECTION

Do not use on fabrics. Store away from heat and humidity.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium palmate, sodium palm kernelate, water, glycerin, palm acid, fragrance, paraffinum liquidum, sodium chloride, palm kernel acid, iron oxides, tetrasodium EDTA, tetrasodium etidronate, FD&C Yellow No. 5, FD&C Blue No. 1.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435989chloroxylenol 0.25 % Medicated Liquid SoapPSN3
1435989chloroxylenol 2.5 MG/ML Medicated Liquid SoapSCD3
1435989chloroxylenol 0.25 % Medicated Liquid SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49698-001-01ASEPSO ANTISEPTIC ORIGINAL1 in 1 CARTONSOAP13
49698-001-01ASEPSO ANTISEPTIC ORIGINAL80 g in 1 BOXSOAP803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49698-001ASEPSO ANTISEPTIC ORIGINAL (CHLOROXYLENOL) SOAP [CODAA SWITZERLAND AG]3Current NDC, 2 package rows20231128_f44ad98f-218d-72ea-e053-2995a90a0c8a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49698-00149698-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PALMATES0A6004K3ZIACT
SODIUM PALM KERNELATE6H91L1NXTWIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PALM ACIDB6G0Y5Z616IACT
MINERAL OILT5L8T28FGPIACT
SODIUM CHLORIDE451W47IQ8XIACT
PALM KERNEL ACID79P21R4317IACT
FERRIC OXIDE RED1K09F3G675IACT
EDETATE SODIUMMP1J8420LUIACT
ETIDRONATE TETRASODIUMCZZ9T1T1X4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CHLOROXYLENOL0F32U78V2QACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ASEPSO ANTISEPTIC ORIGINALCHLOROXYLENOLCODAA Switzerland AGf44ad98f-218d-72ea-e053-2995a90a0c8a2023-11-27WarningsExact identifier
ndc (package): 49698-001-01
ndc (product): 49698-001
ndc11 (package): 49698000101
spl id: 0b27ac6d-eef9-4981-e063-6294a90a62e3
spl set id: f44ad98f-218d-72ea-e053-2995a90a0c8a