MedPath

154 Antibacterial Liquid Hand

Approved
Approval ID

3de748aa-6dd8-470b-e063-6394a90a2e8e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Worklife Brands, LLC

DUNS: 117637415

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chloroxylenol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code80434-701
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Chloroxylenol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (13)

CHLOROXYLENOLActive
Quantity: 1 g in 1 L
Code: 0F32U78V2Q
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED)Inactive
Code: G7SW5QN7TT
Classification: IACT
SODIUM C14-16 OLEFIN SULFONATEInactive
Code: O9W3D3YF5U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BRONOPOLInactive
Code: 6PU1E16C9W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
COCAMIDOPROPYL HYDROXYSULTAINEInactive
Code: 62V75NI93W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

Principal Display

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/3/2025

USES / USOS

Handwash to help decrease bacteria on the skin. / Lavado de manos para ayudar a disminuir las bacterias en la piel.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/3/2025

ACTIVE INGREDIENT / INGREDIENTE ACTIVO

Chloroxylenol 0.1% / Cloroxilenol al 0.1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/3/2025

PURPOSE / OBJETIVO

Antiseptic / Antiséptico

WARNINGS SECTION

LOINC: 34071-1Updated: 9/3/2025

WARNINGS / ADVERTENCIAS

FOR EXTERNAL USE ONLY. / ÚNICAMENTE PARA USO EXTERNO.

DO NOT USEin the eyes. In case of contact, immediately flush eyes with water.
NO USARen los ojos. En caso de contacto, enjuagar inmediatamente con agua .

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/3/2025

STOP USE AND ASK A DOCTOR IF irritation or rash appears and lasts.

DEJE DE USARLO Y CONSULTE A UN MÉDICO SI aparece irritación o sarpullido y persiste.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/3/2025

**KEEP OUT OF REACH OF CHILDREN.**If swallowed, get medical help or contact a Poison Control Center right away.

MANTENER FUERA DEL ALCANCE DE LOS NIÑOS. En caso de ingestión, busque ayuda médica o comuníquese
con un centro de control de intoxicaciones de inmediato.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/3/2025

DIRECTIONS / INSTRUCCIONES:

• Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. / Aplique
una pequeña cantidad de producto en las manos mojadas, haga espuma durante 30 segundos y enjuague bien.
• Children under 6 years of age should be supervised when using this product. / Los niños menores de 6 años
deben ser supervisados cuando utilicen este producto.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/3/2025

INACTIVE INGREDIENTS / INGREDIENTES INACTIVOS:

Water (Agua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (Sulfonato de olefina C14-16 de sodio)
(68439-57-6), Cocamidopropyl Hydroxysultaine (Cocamidopropil hidroxisultaína) (68139-30-0), Sodium
Chloride (Cloruro de sodio) (7647-14-5), Propanediol (Propanodiol) (26264-14-2), Propylene Glycol
(Propilenglicol) (57-55-6), Sodium Polyitaconate (Politaconato de sodio) (26099-89-8), Fragrance (Proprietary)
(Fragancia (Propietaria)), 2-Bromo-2-Nitropropane-1,3-Diol (-bromo-2-nitropropano-1,3-diol) (52-51-7),
Methylisothiazolinone (Metilisotiazolinona) (2682-20-4), Methylchloroisothiazolinone (Metilcloroisotiazolinona)
(26172-55-4), Yellow 5 (Amarillo 5) (1934-21-0), Red 40 (Rojo 40) (25956-17-6).

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154 Antibacterial Liquid Hand - FDA Drug Approval Details