FDA.reportPublic FDA data

Charm-Tex Antibacterial

Manufacturer
Charm-Tex, Inc.
Effective date
2022-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:10:11

Label at a glance#

ProductCharm-Tex Antibacterial
Active ingredientBENZETHONIUM CHLORIDE
Label structure9 sections

Indications and uses

For hand washing to decreases bateria on the skin reduce chance f cross-infection

Dosage and administration

wet skin spread a small amount of soap on hands and forearms scrub well for at least 15 seconds rinse thoroughly after washing and dry

Storage and handling

do not use if seal under cap is torn, broken or missing.

Label contents#

Full prescribing information#

Active Ingredient & Purpose

OTC - ACTIVE INGREDIENT SECTION

Antiseptic

OTC - PURPOSE SECTION

Active IngredientPurpose
Benzethonium choloride 0.1%..............................Antibacterial

Uses

INDICATIONS & USAGE SECTION

For hand washing to

  • decreases bateria on the skin
  • reduce chance f cross-infection

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

on infants under 6 months of age.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops.

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 skin
  • spread a small amount of soap on hands and forearms
  • scrub well for at least 15 seconds
  • rinse thoroughly after washing and dry

Other information

STORAGE AND HANDLING SECTION

  • do not use if seal under cap is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocamidopropyl betaine, coco diethanolamine, edetale disodium anhydrous, FD&C red no. 4 (CI 14700), FD&C yellow no. 5 (CI19140), fragrance, peg-7 glyceryl cocoate, phenoxyethanol, propylene glycol, sodium chloride, sodium lauryl sulphate, water.

Questions & comments?

OTC - QUESTIONS SECTION

1-800-221-3147 (M-F) 9 AM to 5 PM EST or www.charm-tex.com

Exclusive Distributor:

SPL UNCLASSIFIED SECTION

Charm-Tex, Inc.
1618 Coney Island Ave
Brooklyn NY 11230 USA

Made in India
E.C.No: GUJ/COS/GC/1348

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 Gallon (128 oz) 3785 ml

NDC 40057-3100-1

Antibacterial_1 gallonAntibacterial_1 gallon

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40057-310040057-3100-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-7 GLYCERYL COCOATEVNX7251543IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM LAURETH-5 SULFATE410Q7WN1BXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
COCO DIETHANOLAMIDE92005F972DIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT

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
0644c8fb-837a-0c43-e063-6294a90afa52d6ea0f56-28cf-c9e8-e053-2a95a90aa7852023-01-01WarningsExact identifier
spl set id: d6ea0f56-28cf-c9e8-e053-2a95a90aa785

Reported adverse events (FAERS/openFDA)#

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