MedPath

Waxie Antibacterial Hand

Approved
Approval ID

cef33d1e-bc34-3c3d-e053-2995a90aeef2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Waxie's Enterprises, LLC

DUNS: 029142577

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 Code61666-901
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Chloroxylenol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (15)

ACID RED 51Inactive
Code: PN2ZH5LOQY
Classification: IACT
2-BROMO-2-NITROPROPANE-1,3-DIOLInactive
Code: 6PU1E16C9W
Classification: IACT
COCAMIDOPROPYL HYDROXYSULTAINEInactive
Code: 62V75NI93W
Classification: IACT
METHYLCHLOROISOTHIAZOLINONEInactive
Code: DEL7T5QRPN
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLISOTHIAZOLINONEInactive
Code: 229D0E1QFA
Classification: IACT
CHLOROXYLENOLActive
Quantity: 2.5 g in 1 L
Code: 0F32U78V2Q
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
FRAGRANCE 13576Inactive
Code: 5EM498GW35
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED)Inactive
Code: G7SW5QN7TT
Classification: IACT
SODIUM C14-16 OLEFIN SULFONATEInactive
Code: O9W3D3YF5U
Classification: IACT
GLYCOL DISTEARATEInactive
Code: 13W7MDN21W
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/19/2025

Principal Display

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/19/2025

Uses

Handwash to help decrease bacteria on the skin

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/2/2021

Purpose

Antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 12/2/2021

Warning:

For external use only

Do not usein the eyes. In case of contact, immediately flush eyes with water.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 12/2/2021

Stop use and ask doctor ifirritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/2/2021

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/2/2021

Active Ingredient

Chloroxylenol 0.25%.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/11/2024

Directions

• Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
• Children under 6 years of age should be supervised when using this product.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/19/2025

Inactive ingredients

Water (aqua) (7732-18-5), Sodium Lauryl Sulfate (68585-47-7), Cocamidopropyl Hydroxysultaine (68139-30-0), Propylene Glycol (57-55-6), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Sodium C14-16 Olefin Sulfonate (68439-57-6), Glycol Distearate (627-83-8), Fragance (Proprietary), Sodium Polyitaconate (26099-89-8), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Acid Red 51 (16423-68-0).

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