FDA.reportPublic FDA data

CharmTex Anti Bacterial

Manufacturer
Inopak, Ltd.
Effective date
2023-02-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:36:17

Label at a glance#

ProductCharmTex Anti Bacterial
Active ingredientCHLOROXYLENOL
Label structure11 sections

Indications and uses

• Handwash to help reduce bacteria on the skin that    potentially can cause disease. • Recommended for repeated use.

Dosage and administration

• Wet hands with water and dispense sufficient     amount of product into cupped palm of hand. • Wash both hands thoroughly for 15 seconds. • Rinse under running water and dry thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Parachlorometaxylenol 0.3%w/w

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

• Recommended for repeated use.

Warnings

WARNINGS SECTION

Warnings

• For external use only.

• Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

• Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

When using

OTC - WHEN USING SECTION

Keep out of eyes, ears, or mouth.

Stop using

OTC - STOP USE SECTION

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

 In case of eye  contact, flush eyes with water.

Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

• Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

• Wash both hands thoroughly for 15 seconds.

• Rinse under running water and dry thoroughly.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, D&C Red 4, FD&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

Charm-Tex single label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Charm-Tex

Maximum Security

Anti-Bacterial Soap

1 GALLON

Drug Facts

Active Ingredient                                      Purpose

Parachlorometaxylenol 0.3% w/w……. Antiseptic

Uses

• Handwash to help reduce bacteria on the skin that

   potentially can cause disease.

• Recommended for repeated use.

Warnings

• For external use only.

• Keep out of eyes, ears, or mouth. In case of eye 

   contact, flush eyes with water.

• Keep out of reach of children. If swallowed, get

   medical help or contact a Poison Control Center

   right away.

Directions

• Wet hands with water and dispense sufficient

    amount of product into cupped palm of hand.

• Wash both hands thoroughly for 15 seconds.

• Rinse under running water and dry thoroughly.

Inactive ingredients Citric Acid, Cocamide DEA, DMDM Hydantoin, Ethyl Alcohol, FD&C Red 4, D&C Yellow 5, Fragrance, Isopropyl Alcohol, Sodium Chloride, Sodium Laureth Sulfate, Water

MADE IN U.S.A.

CT-CTAB  Rev. 1.1                                                                                             H/CTAB 128

Charm Tex single labelCharm Tex single label

Charm-Tex case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Charm-Tex

Maximum Security

Anti-Bacterial Soap

4/1 GALLONG                                    MADE IN U.S.A.

CT-CTAB-CS Rev. 1.0                        H/CTAB 128

Charm-Tex case labelCharm-Tex case label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58575-406-012023-02-19C16284748780-1f386c64a-1203-0266-e053-dadaa90a7c1aCharmTex Antibacterial Soap 406
58575-406-022023-02-19C16284748780-1f386c64a-1203-0266-e053-dadaa90a7c1aCharmTex Antibacterial Soap 406
58575-406-012023-01-30C16284748780-1f386c64a-1203-0266-e053-dadaa90a7c1aCharmTex Antibacterial Soap 406
58575-406-022023-01-30C16284748780-1f386c64a-1203-0266-e053-dadaa90a7c1aCharmTex Antibacterial Soap 406

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-40658575-406-01, 58575-406-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
DMDM HYDANTOINBYR0546TOWIACT
ALCOHOL3K9958V90MIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ISOPROPYL ALCOHOLND2M416302IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
TRIETHANOLAMINE LAURYL SULFATEE8458C1KAAIACT
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
f51760a8-5f6e-c8cf-e053-2995a90accfaa1eb2dbf-fb28-43e5-bf1a-54be7c5777332023-02-19WarningsExact identifier
spl id: f51760a8-5f6e-c8cf-e053-2995a90accfa
spl set id: a1eb2dbf-fb28-43e5-bf1a-54be7c577733

Reported adverse events (FAERS/openFDA)#

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