MyDerm Medical 5% Lidocain Numbing Spray

Manufacturer
Inspec Solution LLC. | Inspec Solutions LLC.
Effective date
2024-11-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:03:34

Label at a glance#

ProductMyDerm
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE, HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER
Label structure13 sections

Indications and uses

Uses: Temporary shrinks hemorrhoidal tissue •Temporarily reduces swelling associated with irritated anorectal areas.

Dosage and administration

Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •Children under 2 years of age: consult physician.

Label contents#

Full prescribing information#

Active ingerdients

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel Distillate 42.50%

Lidocaine HCl 5.00%

Penylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Witch Hazel Distillate .......................Anesthetic

Lidocaine HCl 5.00% .......................Anesthetic

Penylephrine HCI 0.25% .................Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

Uses: Temporary shrinks hemorrhoidal tissue •Temporarily reduces swelling associated with irritated anorectal areas.

Warning

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

When using this product • avoid spraying in eye• content under pressure •do not puncture or incinerate •do not store at temperature above 120° F •do not exceed recommended daily dosage unless directed by doctor •do not put this product into rectum by using fingers or any mechanical device or applicator

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you have • heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of prostate gland •are presently taking a prescription drug or high blood pressure or depression.

Stop use and ask doctor

OTC - STOP USE SECTION

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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

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 immediately

Directions

DOSAGE & ADMINISTRATION SECTION

Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily •Children under 2 years of age: consult physician.

Question?

OTC - QUESTIONS SECTION

Question? 1-855-myderm1

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Alcohol

Aloe Barbadensis Leaf

Benzophenone-4

Disodium EDTA

Tocopheryl Acetate

Ethylhexylglycrin

Phenoxyethanol

Polysorbate-20

Propylene Glycol

Sodium Citrate

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MyDerm ClinicalMyDerm Clinical

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72667-081-01MyDerm127 g in 1 CANSPRAY1271

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-08172667-081-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
MyDermPENYLEPHRINE HCI, WITCH HAZEL, LIDOCAINE HCL,Inspec Solution LLC.2618eba1-9308-a666-e063-6394a90ac3d22024-11-04WarningsExact identifier
ndc (package): 72667-081-01
ndc (product): 72667-081
ndc11 (package): 72667008101
spl id: 2618eba1-9309-a666-e063-6394a90ac3d2
spl set id: 2618eba1-9308-a666-e063-6394a90ac3d2

Reported adverse events (FAERS/openFDA)#

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