FDA.reportPublic FDA data

MyDerm Bite Relief Mediocated Ointment

Manufacturer
Inspec Solutions LLC.
Effective date
2025-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:35:26

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

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
72667-01972667-019-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PEG-8 DIMETHICONEGIA7T764ODIACT
PEPPERMINT OILAV092KU4JHIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
PEG-2 STEARATE94YQ11Y95FIACT
EDETATE DISODIUM7FLD91C86KIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
CLOVE OIL578389D6D0IACT
PROPYLENE GLYCOL 1,2-DISTEARATET65PN3O37HIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
ALOEV5VD430YW9IACT
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
ALCOHOL3K9958V90MIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
MENTHOLL7T10EIP3AIACT
HYDROCORTISONEWI4X0X7BPJIACT
BENZOCAINEU3RSY48JW5ACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4af344dc-c75c-a66c-e063-6394a90ad3d358b86956-0192-4e93-9ca5-c41df6f9ea192026-02-16WarningsExact identifier
spl set id: 58b86956-0192-4e93-9ca5-c41df6f9ea19
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
ndc (product): 72667-019

Reported adverse events (FAERS/openFDA)#

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