FDA.reportPublic FDA data

Antiseptic

Manufacturer
Total Resources International
Effective date
2020-01-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:53

Label at a glance#

ProductAntiseptic
Active ingredientalcohol, lidocaine hydrochloride
Label structure8 sections

Indications and uses

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Dosage and administration

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 50.0% v/v

Lidocaine HCI 2.0% w/w

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent infection in minor scrapes and temporary relief of itching of insect bites

Warnings

WARNINGS SECTION

For external use only.

Flammable, keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • over large areas of the body
  • in eyes
  • over raw or blistered areas.
OTC - STOP USE SECTION

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older: Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, menthol, purified water

Principal Display Panel – Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BE SMART

GET PREPARED

STING
RELIEF WIPE

1 PC

Pre-moistened Wipe

SINGLE USE

Made in USA • Mfd. for: TOTAL RESOURCES INTL. • Walnut, California 91789

00-BEE-90103 Rev.01 • NDC #55550-100-02

Figure
Figure

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-100-022022-01-28C16284748780-1d6a99b39-37c7-a426-e053-dadaa90af4c29071794c-3848-46e6-aa63-02008b42dc09

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-100-02Antiseptic0.8 g in 1 POUCHLIQUID0.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-100ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [TOTAL RESOURCES INTERNATIONAL]1Legacy NDC, 1 package rows20200114_9071794c-3848-46e6-aa63-02008b42dc09.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55550-10055550-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
alcohol3K9958V90MACTIB
lidocaine hydrochlorideV13007Z41AACTIR
benzalkonium chlorideF5UM2KM3W7IACT
mentholL7T10EIP3AIACT
water059QF0KO0RIACT

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
c628a672-175c-4867-82cf-e8fa1b459fd39071794c-3848-46e6-aa63-02008b42dc092020-01-14WarningsExact identifier
spl id: c628a672-175c-4867-82cf-e8fa1b459fd3
spl set id: 9071794c-3848-46e6-aa63-02008b42dc09

Reported adverse events (FAERS/openFDA)#

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