FDA.reportPublic FDA data

Waxie Clear Tone Antibacterial

Manufacturer
Waxie's Enterprises, LLC | Midlab, Inc.
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:00

Label at a glance#

ProductWaxie Clear Tone Antibacterial
Active ingredientCHLOROXYLENOL
Label structure9 sections

Indications and uses

 Handwash to help decrease bacteria on the skin.

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

PCMX 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic Handwashing

Uses

INDICATIONS & USAGE SECTION

 Handwash to help decrease bacteria on the skin.

Warning:

WARNINGS SECTION

For external use only
Do not use in the eyes. In case of contact, flush thoroughly with water.

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Sodium Laureth-3 Sulfate,
Sodium Chloride, Propylene glycol, Propanediol, Fragrance, Methylchloroisothiazolinone,
Methylisothiazolinone, Yellow 5, and Red 40.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61666-70161666-701-41

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 CHLORIDE451W47IQ8XIACT
PROPANEDIOL5965N8W85TIACT
CINNAMALDEHYDESR60A3XG0FIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EUGENOL3T8H1794QWIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
WATER059QF0KO0RIACT
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
f7e7e786-ed13-7666-e053-6394a90a1a47c6ed6aa1-109f-b9fd-e053-2a95a90a45ce2023-03-27WarningsExact identifier
spl set id: c6ed6aa1-109f-b9fd-e053-2a95a90a45ce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.