FDA.reportPublic FDA data

Sooth-a-Sting

Manufacturer
HART Health | JAMES ALEXANDER CORPORATION
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:35

Label at a glance#

ProductSooth-a-Sting
Active ingredientBENZOCAINE, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Temporarily relief of pain and itching associated with insect bites insect stings

Dosage and administration

remove stinger carefully reverse cardboard sleeve crush tube between thumb and forefinger to release fluid apply on and aroundpoint of insect puncture do not reuse swab dispose of swab properly

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

L-Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relief of pain and itching associated with

  • insect bites
  • insect stings

Warnings

WARNINGS SECTION

For external use only

  • do not get in eyes
  • not for prolonged use

Allergy alert: A severe allertig reaction to insect bites and stings may require life support measures. In such cases, immediately call 911 or your local emergency provider.

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes or over large portions of the body
  • more than 3-4 times daily

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition persists
  • unusual redness, swelling, rash, or irritation 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

  • remove stinger carefully
  • reverse cardboard sleeve
  • crush tube between thumb and forefinger to release fluid
  • apply on and aroundpoint of insect puncture
  • do not reuse swab
  • dispose of swab properly

Inactive Ingredient

INACTIVE INGREDIENT SECTION

D&C green dye#5, D&C yellow dye #10, FD&C blue dye #1, PEG 300 NF, isopropyl alcohol, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0440StingSwab23f.jpg0440StingSwab23f.jpg0440StingSwab23f.jpg0440StingSwab23f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037117benzocaine 20 % / menthol 1 % Medicated PadPSN3
1037117benzocaine 200 MG/ML / menthol 10 MG/ML Medicated PadSCD3
1037117benzocaine 20 % / menthol 1 % Topical SwabSY3

DailyMed Pharmacologic Classes#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0050SOOTH-A-STING (BENZOCAINE) SWAB [HART HEALTH]3Current NDC, Legacy NDC20240119_bd7229b6-813a-4149-bfe2-fe682f270ff4.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-005050332-0050-0, 50332-0050-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
D&C GREEN NO. 58J6RDU8L9XIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT

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
Sooth-a-StingBENZOCAINEHART Healthbd7229b6-813a-4149-bfe2-fe682f270ff42024-01-18WarningsExact identifier
ndc (package): 50332-0050-0
ndc (package): 50332-0050-4
ndc (product): 50332-0050
ndc11 (package): 50332005004
ndc11 (package): 50332005000
spl id: 4ca45a41-0ec1-49fa-adc2-4cc3453120a9
spl set id: bd7229b6-813a-4149-bfe2-fe682f270ff4

Reported adverse events (FAERS/openFDA)#

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