Mirakel Pain and Itch Relief

Manufacturer
Sanvio, Inc. | Derma Care Research Labs, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:02

Label at a glance#

ProductMirakel Pain and Itch Relief
Active ingredientBENZOCAINE, RESORCINOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%, Resorcinol 3%

OTC - PURPOSE SECTION


Topical analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain associated with minor burns, minor skin irritations, minor cuts, insect bites or stings, scrapes, and sunburns.

WARNINGS SECTION

For external use only. Do not use over large areas of the body. Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes, use only as directed. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, itching, rash or irritation develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Water, mineral oil, cetyl alcohol, propylene glycol, glyceryl stearate, PEG-100 stearate, isopropyl palmitate, ocimum basilicum (basil) leaf extract, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, chrysanthemum parthenium (feverfew) extract, melia azadirachta leaf extract, glycerin, tocopheryl acetate, aloe barbadensis leaf extract, retinyl palmitate, cholecalciferol, mentha piperita (peppermint) oil, zea mays (corn) oil, isopropyl myristate, carbomer, triethanolamine, lanolin, disodium EDTA, sodium sulfite, methylparaben.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248341benzocaine 20 % / resorcinol 3 % Topical CreamPSN2
248341benzocaine 200 MG/ML / resorcinol 30 MG/ML Topical CreamSCD2
248341benzocaine 20 % / resorcinol 3 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78589-233-02Mirakel Pain and Itch Relief95 g in 1 TUBECREAM952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78589-233MIRAKEL PAIN AND ITCH RELIEF (BENZOCAINE 20%, RESORCINOL 3%) CREAM [SANVIO, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_ed34d728-0275-e209-e053-2995a90a93ff.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78589-23378589-233-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
Mirakel Pain and Itch ReliefBENZOCAINE 20%, RESORCINOL 3%Sanvio, Inc.ed34d728-0275-e209-e053-2995a90a93ff2024-12-20WarningsExact identifier
ndc (package): 78589-233-02
ndc (product): 78589-233
ndc11 (package): 78589023302
spl id: 29b77abb-b9cb-c24d-e063-6394a90a8110
spl set id: ed34d728-0275-e209-e053-2995a90a93ff

Reported adverse events (FAERS/openFDA)#

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