FDA.reportPublic FDA data

WOUND WIPES

Manufacturer
HART Health
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:30:15

Label at a glance#

ProductWOUND WIPES
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

First aid topical antiseptic to help prevent infection in: minor cuts scrapes burns abrasions

Dosage and administration

Adults and chldren 12 years of age and over: apply topically to the clean affected area 1 to 3 times daily when dry, may be covered with a sterile bandage if gets in eyes, flush thoroughly with water Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid topical antiseptic to help prevent infection in:

  • minor cuts
  • scrapes
  • burns
  • abrasions

Warnings

WARNINGS SECTION

For external use only

FLAMMABLE keep away from heat and flame

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large portions of the body
  • on serious burns
  • on animal bites
  • on deep or puncture wounds

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms last more than 72 hours
  • redness, swelling, irritation, or pain occurs

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. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and chldren 12 years of age and over:

  • apply topically to the clean affected area 1 to 3 times daily
  • when dry, may be covered with a sterile bandage
  • if gets in eyes, flush thoroughly with water

Children under 12 years of age:

  • ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN9
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD9
1038558benzalkonium chloride 0.13 % Topical ClothSY9
1038558benzalkonium chloride 0.13 % Topical SwabSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY9
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0043-02022-03-11C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-22022-03-11C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-52022-03-11C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-72022-03-11C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-02021-01-29C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-22021-01-29C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-52021-01-29C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes
50332-0043-72021-01-29C16284748780-1ba0f9c33-3495-a910-e053-dadaa90a0b85Wound Wipes

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-004350332-0043-2, 50332-0043-0, 50332-0043-3, 50332-0043-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
WOUND WIPESBENZALKONIUM CHLORIDEHART Health4942195e-2941-4111-8ab7-2891c316bd272025-12-31WarningsExact identifier
ndc (package): 50332-0043-2
ndc (package): 50332-0043-0
ndc (package): 50332-0043-7
ndc (package): 50332-0043-3
ndc (product): 50332-0043
ndc11 (package): 50332004302
ndc11 (package): 50332004307
ndc11 (package): 50332004300
ndc11 (package): 50332004303
spl id: 5b191e12-bbf7-42ff-b8b6-8f5c43f93966
spl set id: 4942195e-2941-4111-8ab7-2891c316bd27

Reported adverse events (FAERS/openFDA)#

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