FDA.reportPublic FDA data

Sanvio Mirakel Cream

Manufacturer
Sanvio, Inc.
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:21:38

Label at a glance#

Productmirakel
Active ingredientBENZOCAINE, RESORCINOL
Label structure10 sections

Indications and uses

Uses temporary relief of pain, itching and discomfort associated with: ■ rashes ■ minor cuts ■ minor burns ■ minor skin irritations ■ insect bites

Dosage and administration

Directions ■ adults and children 12 years and older: apply small amount to affected area not more than 3-4 times a day. ■ children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic

Active IngredientsActive Ingredients

Uses

INDICATIONS & USAGE SECTION

Uses temporary relief of pain, itching and discomfort associated with:

■ rashes
■ minor cuts

■ minor burns
■ minor skin irritations

■ insect bites

UsesUses

Warnings

WARNINGS SECTION

WarningWarning

Warnings
For external use only
When using this product ■ avoid contact with eyes ■ do not apply
over large areas of the body

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

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

Keep Out Of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of ChildrenKeep Out Of Reach Of Children

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

Directions

DOSAGE & ADMINISTRATION SECTION

DirectionsDirections

Directions
■ adults and children 12 years and older: apply small amount to
affected area not more than 3-4 times a day.
■ children under 12 years of age: consult a doctor

Other Information

OTHER SAFETY INFORMATION

Other InformationOther Information

Other Information ■ store at 20-25°C (68-77°F)
■ skin is more sensitive to sunlight when using this product.
■ keep tightly closed after use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive IngredientsInactive Ingredients

Inactive ingredients aloe barbadensis (aloe vera) leaf extract,
butylated hydroxytoluene, carbomer, cetyl
alcohol, cholecalciferol, edetate disodium,
glyceryl monostearate, isopropyl palmitate,
maltodextrin, mentha piperita (peppermint) oil,
methylparaben, mineral oil, PEG-40 hydrogenated
castor oil, PEG-100 stearate,petrolatum,
propylene glycol, propyl-paraben, purified
water, retinyl palmitate, sodium lauryl sulfate,
thymus vulgaris (thyme) flower leaf oil, tocopheryl
acetate triethanolamine, xanthan gum.

Questions

OTC - QUESTIONS SECTION

QuestionsQuestions

Questions? Call 1-888-855-5681

Purpose

OTC - PURPOSE SECTION

PurposePurpose


Active ingredients Purpose
Benzocaine 10% .........................................................External Analgesic
Resorcinol 1.50%........................................................External Analgesic

Pricipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Main CompleteLabel Main Complete

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2377375benzocaine 10 % / resorcinol 1.5 % Topical CreamPSN2
2377375benzocaine 100 MG/ML / resorcinol 15 MG/ML Topical CreamSCD2
2377375benzocaine 10 % / resorcinol 1.5 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78589-100-012022-01-28C16284748780-1d6a99b39-43a9-a426-e053-dadaa90af4c2Sanvio Mirakel Cream
78589-100-022022-01-28C16284748780-1d6a99b39-43a9-a426-e053-dadaa90af4c2Sanvio Mirakel Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78589-100-01mirakel1 g in 1 TUBECREAM12
78589-100-02mirakel1 g in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78589-100MIRAKEL (BENZOCINE 10%, RESORCINOL 1.5%) CREAM [SANVIO, INC.]2Legacy NDC, 2 package rows20200717_a3f56fca-341a-57c6-e053-2a95a90a78bd.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78589-10078589-100-01, 78589-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
RESORCINOLYUL4LO94HKACTIB
CETYL ALCOHOL936JST6JCNIACT

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
aa7e0774-7f59-5c44-e053-2995a90aa8fea3f56fca-341a-57c6-e053-2a95a90a78bd2020-07-15WarningsExact identifier
spl id: aa7e0774-7f59-5c44-e053-2995a90aa8fe
spl set id: a3f56fca-341a-57c6-e053-2a95a90a78bd

Reported adverse events (FAERS/openFDA)#

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