FDA.reportPublic FDA data

Cut Care Insect Bite Antiseptic and Pain Relieving Wipe

Manufacturer
Zeus Medical Holdings LLC
Effective date
2013-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:36:54

Label at a glance#

ProductCut Care Insect Bite Antiseptic and Pain Relieving Wipe
Active ingredientBENZOCAINE, ISOPROPYL ALCOHOL
Label structure10 sections

Indications and uses

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Dosage and administration

Adults and children 2 years of age and older, apply to affected area 3-4 times daily. Children under 2 years; consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine, 6% w/v

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from fire or flame.

Do Not Use

OTC - DO NOT USE SECTION

  • With electrocautery procedures.
  • In eyes

Stop Use

OTC - STOP USE SECTION

  • If irritation and redness develop.
  • If condition persists for more than 72 hours, consult a physician.

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

  • Adults and children 2 years of age and older, apply to affected area 3-4 times daily.
  • Children under 2 years; consult a physician.

Other Information

SPL UNCLASSIFIED SECTION

Avoid excessive heat. Store at room temperature: 15 - 30 degrees C (59 - 86 degrees F)

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53439-120-10
Cut Care
Insect Bite Antiseptic & Pain Relieving Wipes
First aid antiseptic
Topical Analgesic
Contents: 100 Pre-Moistened Wipes

NDC 53439-120-10 Cut Care Insect Bite Antiseptic & Pain Relieving Wipes First aid antiseptic Topical Analgesic Contents: 100 Pre-Moistened WipesNDC 53439-120-10 Cut Care Insect Bite Antiseptic & Pain Relieving Wipes First aid antiseptic Topical Analgesic Contents: 100 Pre-Moistened Wipes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
809206benzocaine 6 % / isopropyl alcohol 70 % Medicated PadPSN2
809206benzocaine 60 MG/ML / isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
809206benzocaine 6 % / isopropyl alcohol 70 % Medicated PadSY2
809206benzocaine 6 % / isopropyl alcohol 70 % Topical SwabSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53439-120-102019-11-27C16284748780-19855d018-ee3a-cd31-e053-dbdaa90ab51aCut Care Insect Bite Antiseptic and Pain Relieving Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53439-120-01Cut Care Insect Bite Antiseptic and Pain Relieving Wipe1 in 1 POUCHSWAB12
53439-120-10Cut Care Insect Bite Antiseptic and Pain Relieving Wipe100 in 1 CARTONSWAB1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53439-120CUT CARE INSECT BITE ANTISEPTIC AND PAIN RELIEVING WIPE (BENZOCAINE AND ISOPROPYL ALCOHOL) SWAB [ZEUS MEDICAL HOLDINGS LLC]2Legacy NDC, 2 package rows20130915_73fd4fa1-5c14-4c8d-a3c2-75fdb8d6bd75.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW52
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
BENZOCAINEACTIVE MOIETYU3RSY48JW52
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

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
53439-12053439-120-01, 53439-120-10

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
BENZOCAINEU3RSY48JW5ACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
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
cc58d0da-6bde-49eb-b3df-fd6a542939dd73fd4fa1-5c14-4c8d-a3c2-75fdb8d6bd752013-09-16WarningsExact identifier
spl id: cc58d0da-6bde-49eb-b3df-fd6a542939dd
spl set id: 73fd4fa1-5c14-4c8d-a3c2-75fdb8d6bd75

Reported adverse events (FAERS/openFDA)#

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