Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E

Manufacturer
Fourstar Group USA, Inc.
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:02

Label at a glance#

ProductTheraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

for adults and children of 2 years and over children under 2 year ask a doctor before use allow to dry without wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

decreases bacteria on skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • over large areas of the body
  • if you are allergic to any of the ingredients

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash develops and continues for more than 72 hours.

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

  • for adults and children of 2 years and over
  • children under 2 year ask a doctor before use
  • allow to dry without wiping

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Phenoxyethanol, Polysorbate 20, Aloe Barbadensis Leaf Extract, Polyaminopropyl Biguanide, Disodium EDTA, Fragrance, 2-Bromo-2-Nitropropane-1,3-Diol, Tocopheryl Acetate

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038856benzalkonium Cl 0.1 % Medicated PadPSN2
1038856benzalkonium chloride 1 MG/ML Medicated PadSCD2
1038856benzalkonium chloride 0.1 % Medicated WipesSY2
1038856benzalkonium chloride 0.1 % Topical SwabSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-007-20Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E3.5 mL in 1 PATCHCLOTH3.52
80684-007-20Theraplus Antibacterial Wipes Fresh Scent with Aloe and Vitamin E20 in 1 BAGCLOTH202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-007THERAPLUS ANTIBACTERIAL WIPES FRESH SCENT WITH ALOE AND VITAMIN E (BENZALKONIUM CHLORIDE) CLOTH [FOURSTAR GROUP USA, INC.]2Legacy NDC, 2 package rows20231027_b3ece54b-6e1e-08a7-e053-2a95a90a363e.zip

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
80684-00780684-007-20

Ingredients#

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

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

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
5a187b53-d7dd-e809-e063-6294a90a9566b3ece54b-6e1e-08a7-e053-2a95a90a363e2026-08-28WarningsExact identifier
spl set id: b3ece54b-6e1e-08a7-e053-2a95a90a363e

Reported adverse events (FAERS/openFDA)#

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