FDA.reportPublic FDA data

1407 Medicaine Insect Bite (Ampule) 67777-405-01

Manufacturer
Dynarex Corporation
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-06-04 05:10:13

Label at a glance#

ProductMedicaine Sting and Bite
Active ingredientBENZOCAINE
Label structure10 sections

Dosage and administration

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bit. May be used on affected area(s) up to 4 times per day Not for use with children less than 2 years old without medical advise.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine USP 20%

Purpose

OTC - PURPOSE SECTION

Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

L-Menthol USP 1%

Purpose

OTC - PURPOSE SECTION

Analgesic

Use(s)

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with insect bites and stings.

Warnings

WARNINGS SECTION

For External Use Only

When Using Section

OTC - WHEN USING SECTION

• Do not use in the eyes

• Not for prolonged use

• Do not apply other medication to the same affected areas unless advised by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition persists, or if a rash, irritation, or allergic reaction develops.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Reverse cardboard sleeve then crush at dot between thumb and forefinger. Once solution has saturated tip, apply topically to the sting or bit. May be used on affected area(s) up to 4 times per day

Not for use with children less than 2 years old without medical advise.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature 15º-30ºC (59º-86ºF) away from light.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

D&C Green Dye #5, D&C Yellow Dye #10, FD&C Blue Dye #1, Isopropyl Alcohol, PEG 300 NF, Purified Water USP

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1407 BX MASTER1407 BX MASTER1407 Medicaine Sting and Bite Ampule

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130616784140728GTIN-13: 0616784140728
EAN-13: 0616784140728
GTIN-12: 616784140728
UPC-A: 616784140728
GTIN storage (14 digits): 00616784140728		1407 BX MASTER (R230907-2).jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-405-02EA - Each67777-405b07115a2-f0c6-4404-b87f-3190e497daac12024-11-05
67777-405-03EA - Each67777-4056289b5ae-59b1-4a44-ba76-b6432aef766b12024-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW51
BenzocaineACTIVE MOIETYU3RSY48JW51
MentholINACTIVE INGREDIENTL7T10EIP3A1

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
67777-40567777-405-01, 67777-405-02, 67777-405-03

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
D&C GREEN NO. 58J6RDU8L9XIACT
BENZOCAINEU3RSY48JW5ACTIB
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
ISOPROPYL ALCOHOLND2M416302IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-06-24full-release2026-06-01 00:14:06

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 1 · 16 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
16 equally ranked IID candidates
MentholMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii+route
16 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
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
ndc (package): 67777-405-02
ndc (package): 67777-405-01
ndc (package): 67777-405-03
ndc (product): 67777-405
ndc11 (package): 67777040501
ndc11 (package): 67777040502
ndc11 (package): 67777040503
spl id: 4a021b4a-2370-b5df-e063-6394a90a7913
spl set id: b721607e-e36b-4691-a824-c8f520bd6386

Reported adverse events (FAERS/openFDA)#

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