FDA.reportPublic FDA data

Antimicrobial Wipes Alcohol Free

Manufacturer
Valley of the Sun Cosmetics LLC
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:41

Label at a glance#

ProductAntimicrobial Wipes Alcohol Free
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

Antimicrobial Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss. Open and unfold wipe Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry. For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe. Discard after single use Supervise childr...

Storage and handling

Store between 15-30ºC (59-86°F) Avoid freezing and excessive heat above 40ºC(104°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Antimicrobial Wipes are used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not Use

OTC - DO NOT USE SECTION

  • in children less than 2 years of age, do not use as baby wipe.
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

If irritation or rash occurs. These may be signs of a serious condition.

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

  • To dispense, lift cover, remove seal, pull center sheet from roll, twist to a point and feed through dispenser hole in cover. Keep lid closed to prevent moisture loss.
  • Open and unfold wipe
  • Thoroughly wipe hands, fingers and wrists. Be sure to use the entire wipe. Allow to dry.
  • For dirty hands, use first wipe to clean hands, then discard wipe; sanitize with the second wipe.
  • Discard after single use
  • Supervise children under 2 years of age when using this product to avoid swallowing

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30ºC (59-86°F)
  • Avoid freezing and excessive heat above 40ºC(104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Aloe barbadensis (aloe vera) leaf extract, Hydrogen Peroxide, Tocopheryl Acetate (Vitamin E), PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Phenoxyethanol

Label and product picture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

80 wipes in 1 canister, NDC: 76523-094-80

LabelLabelProduct picture FrontProduct picture Front

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76523-094-802022-01-28C16284748780-1d6a99b39-7ed9-a426-e053-dadaa90af4c2Antimicrobial Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76523-094-80Antimicrobial Wipes Alcohol Free100 g in 1 CANISTERCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76523-094ANTIMICROBIAL WIPES ALCOHOL FREE (BENZALKONIUM CHLORIDE) CLOTH [VALLEY OF THE SUN COSMETICS LLC]1Legacy NDC, 1 package rows20201116_b3f3a44e-20d2-bc95-e053-2995a90aac06.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76523-09476523-094-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-60 HYDROGENATED CASTOR OIL02NG325BQGIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
b3f3a44e-20d3-bc95-e053-2995a90aac06b3f3a44e-20d2-bc95-e053-2995a90aac062020-11-12WarningsExact identifier
spl id: b3f3a44e-20d3-bc95-e053-2995a90aac06
spl set id: b3f3a44e-20d2-bc95-e053-2995a90aac06

Reported adverse events (FAERS/openFDA)#

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