MyDerm Bite Relief Mediocated Ointment

Manufacturer
Inspec Solutions LLC.
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:13

Label at a glance#

ProductMyDerm Bite Relief
Active ingredientBENZOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Benzocaine - 5.0%

OTC - PURPOSE SECTION


Benzocaine - 10.0% ............Pain Relief

INDICATIONS & USAGE SECTION

Temporary relief of pain and itching associated with insect bites

WARNINGS SECTION

For external use only

When using this product • avoid contact with the eye

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: consult a physician

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract

Camphor

Chamomilla Recutita (Matricaria) Flower Extract

Diazolidinyl Urea

Disodium EDTA

Eugenia Caryophyllus (Clove) Flower Oil

Hydrocortisone

Inactive Ingredients:

Mentha Piperita (Peppermint) Oil

Menthol

Methylparaben

Olea Europaea (Olive) Fruit Oil

Papain

PEG-2 Stearate

PEG-2 Stearate SE

Polyethylene

Propylene Glycol

Propylparaben

SD Alcohol 40

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MyDerm Bite ReliefMyDerm Bite Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251295benzocaine 5 % Topical OintmentPSN3
251295benzocaine 0.05 MG/MG Topical OintmentSCD3
251295benzocaine 5 % Topical OintmentSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72667-019-012025-02-01C16284748780-12cef2736-5986-d83d-e063-dadaa90ab31fMyDerm Bite Relief Mediocated Ointment
72667-019-012025-01-30C16284748780-12cef2736-5986-d83d-e063-dadaa90ab31fMyDerm Bite Relief Mediocated Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72667-019-01MyDerm Bite Relief50 g in 1 TUBEOINTMENT503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72667-019MYDERM BITE RELIEF (BENZOCAINE) OINTMENT [INSPEC SOLUTIONS LLC.]3Current NDC, Legacy NDC, 1 package rows20250202_88615668-16b5-7840-e053-2a95a90a9208.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-01972667-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
ndc (package): 72667-019-01
ndc (product): 72667-019
ndc11 (package): 72667001901
spl id: 2d07a8c9-17a4-1727-e063-6394a90a801d
spl set id: 88615668-16b5-7840-e053-2a95a90a9208

Reported adverse events (FAERS/openFDA)#

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