FDA.reportPublic FDA data

Antiseptic

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:32

Label at a glance#

ProductAntiseptic
Active ingredientALCOHOL, LIDOCAINE HYDROCHLORIDE
Label structure10 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. Inactive ingredients benzalkonium chloride, menthol, purified water

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Antiseptic towelette

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

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 doctorif 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 a 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 INGREDIENT SECTION

Inactive ingredientsbenzalkonium chloride, menthol, purified water

PRINCIPAL DISPLAY PANEL – mini pouch label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Contents: 1 single-use, premoistened towelette

Manufactured by SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 800-456-7077 www.safetec.com

EXP. LOT

PRINCIPAL DISPLAY PANEL – mini pouch label
PRINCIPAL DISPLAY PANEL – mini pouch label

PRINCIPAL DISPLAY PANEL – 150 count box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec

NDC 61010-5200-4

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

Reorder No.
52004

Contents: 150 single-use, premoistened towelettes

PRINCIPAL DISPLAY PANEL – 150 count box
PRINCIPAL DISPLAY PANEL – 150 count box

PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5200-1

Safetec

Sting Relief
Insect Bite
Antiseptic and Pain Reliever

2 fl. oz. (59.1 ml)

Reorder No.
52001
Package Not Child Resistant

PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle
PRINCIPAL DISPLAY PANEL – 2 fl. oz. bottle

Principal Display Panel – 25 Count Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-5200-7

Safetec

Sting Relief

Insect Bite

Antiseptic and Pain Reliever

Contents: 25 single-use, premoistened towelettes

Principal Display Panel – 25 Count Box Label
Principal Display Panel – 25 Count Box Label

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
61010-5200-12024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-22024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-42024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-52024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-62024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-72024-02-13C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-12024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-22024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-42024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-52024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-62024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief
61010-5200-72024-01-30C16284748780-11030e365-27a3-111a-e063-dadaa90a10e261010-5200, Sting Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5200-1Antiseptic56 g in 1 BOTTLELIQUID564
61010-5200-2Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-2Antiseptic100 in 1 BOXLIQUID1004
61010-5200-3Antiseptic0.8 g in 1 PACKETLIQUID0.84
61010-5200-4Antiseptic150 in 1 BOXLIQUID1504
61010-5200-5Antiseptic10 in 1 BOXLIQUID104
61010-5200-6Antiseptic20 in 1 BOXLIQUID204
61010-5200-6Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-7Antiseptic1.8 g in 1 PACKETLIQUID1.84
61010-5200-7Antiseptic25 in 1 BOXLIQUID254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5200ANTISEPTIC (ALCOHOL, LIDOCAINE HYDROCHLORIDE) LIQUID [SAFETEC OF AMERICA, INC.]4Current NDC, Legacy NDC, 10 package rows20240214_71aeaf86-2b4d-4945-9606-a9db0ab6b726.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
alcoholACTIVE INGREDIENT3K9958V90M1
lidocaine hydrochlorideACTIVE INGREDIENTV13007Z41A1
alcoholACTIVE MOIETY3K9958V90M1
lidocaineACTIVE MOIETY98PI2009871
alcoholINACTIVE INGREDIENT3K9958V90M1
lidocaine hydrochlorideINACTIVE INGREDIENTV13007Z41A1

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
61010-520061010-5200-1, 61010-5200-3, 61010-5200-4, 61010-5200-5, 61010-5200-2, 61010-5200-6, 61010-5200-7

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 120 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii+dosage form
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
120 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
120 equally ranked IID candidates

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
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
ndc (package): 61010-5200-2
ndc (package): 61010-5200-1
ndc (package): 61010-5200-4
ndc (package): 61010-5200-6
ndc (package): 61010-5200-5
ndc (package): 61010-5200-7
ndc (package): 61010-5200-3
ndc (product): 61010-5200
ndc11 (package): 61010520004
ndc11 (package): 61010520003
ndc11 (package): 61010520001
ndc11 (package): 61010520006
ndc11 (package): 61010520007
ndc11 (package): 61010520005
ndc11 (package): 61010520002
spl id: 10d353b1-16fc-5ddd-e063-6294a90a8fd7
spl set id: 71aeaf86-2b4d-4945-9606-a9db0ab6b726

Reported adverse events (FAERS/openFDA)#

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