Mirakel Pain Relief Roll-On

Manufacturer
Sanvio, Inc. | Derma Care Research Labs, LLC
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:02

Label at a glance#

ProductMirakel Pain Relief Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical anesthetic

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain.

WARNINGS SECTION

For external use only.

Flammable--keep away from fire or flame.

Do not use

  • if you have an allergic reaction to lidocaine or other local anesthetics
  • on large areas of the body or on cut, irritated, blistered, or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

Stop use and ask a doctor if

  • condition worsens
  • severe burning sensation, redness, rash, or irritation develops
  • symptoms persist for more than 7 days or clear p and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Clean affected area before applying product. Adults and children 12 years and older: apply to the affected area not more than 3 to 4 times daily. Children under 12 years old: ask a doctor.

INACTIVE INGREDIENT SECTION

Water, Alcohol Denat., Glyceryl Stearate, Cetearyl Alcohol, Dimethicone, Aminomethyl Propanol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Salix Alba (Willow) Bark Extract, Curcuma Longa (Turmeric) Root Extract, Mentha Piperita (Peppermint) Leaf Extract, Eucalyptus Globulus Leaf Oil, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Ceteth-20 Phosphate, Dicetyl Phosphate, Disodium EDTA, Ethylhexylglycerin, Steareth-21, Methylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78589-257-03Mirakel Pain Relief Roll-On85 g in 1 BOTTLEGEL851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78589-257MIRAKEL PAIN RELIEF ROLL-ON (LIDOCAINE HCL) GEL [SANVIO, INC.]1Current NDC, 1 package rows20240131_102f3618-13ad-37e3-e063-6294a90a8086.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78589-25778589-257-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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 Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
ndc (package): 78589-257-03
ndc (product): 78589-257
ndc11 (package): 78589025703
spl id: 102f3618-13ae-37e3-e063-6294a90a8086
spl set id: 102f3618-13ad-37e3-e063-6294a90a8086

Reported adverse events (FAERS/openFDA)#

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