FDA.reportPublic FDA data

PainFix Restore Patch

Manufacturer
PainFix LLC
Effective date
2019-02-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:34

Label at a glance#

ProductPainFix Restore
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains

Dosage and administration

Adults and children above 12 years: open pouch and remove patch peel off protective backing and carefully apply sticky side to affected area if affected area is large, use more than one patch for best results use each patch for up to 15 hours apply a new patch each day to better keep the patch in place, use the provided adhesive plasters for best results, use with recommended exercises Children 12 years and younge...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

Purpose

OTC - PURPOSE SECTION

`Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves aches and pains of joints and muscles associated with: • backache • arthritis • bursitis • tendonits • cramps • strains • bruises • sprains

Warnings

WARNINGS SECTION

Avoid direct contact with eyes. For external use only.

When using this product

OTC - WHEN USING SECTION

• use only as directed • avoid contact with eyes or mucous membranes • do not apply local heat to the area of use • do not apply to wounds, broken, damaged or irritated skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens or symptoms persist for more than 7 days • skin irritation develops or you experience signs of skin injury, such as pain, swelling, or blistering where product is applied

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children above 12 years:

  • open pouch and remove patch
  • peel off protective backing and carefully apply sticky side to affected area
  • if affected area is large, use more than one patch for best results
  • use each patch for up to 15 hours
  • apply a new patch each day
  • to better keep the patch in place, use the provided adhesive plasters
  • for best results, use with recommended exercises

Children 12 years and younger, ask a health professional

Other Information

SPL UNCLASSIFIED SECTION

Store in a cool, dry place, away from direct sunlight.

Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis extract, Aluminum glycinate, Angelica anomala extract, Carthamus tinctorius extract, Cinnamomum camphora extract, Cinnamomum cassia extract, Citrus reticulata extract, Commiphora molmol extract, Curcuma longa extract, Curcuma zedoaria extract, Daemonops draco extract, Disodium EDTA, Drynaria fortunei extract, Glycerine, Glyceryl stearate, Kaolin, Methylparaben, PEG-40 hydrogenated castor oil, Pistacia lentiscus extract, Polyvinylpyrrolidone, Rheum officinale extract, Sodium polyacrylate, Scutellaria baicalenis extract, Tartaric acid, Water (Aqua)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046205menthol 3 % Medicated PatchPSN2
1046205menthol 0.03 MG/MG Medicated PatchSCD2
1046205menthol 3 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72749-000-002021-07-23C16284748780-1c7ccaba7-1977-fd44-e053-dadaa90aa01bPainFix Restore Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72749-000-00PainFix Restore1 in 1 PACKETPATCH12
72749-000-00PainFix Restore5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72749-000PAINFIX RESTORE (MENTHOL) PATCH [PAINFIX LLC]2Legacy NDC, 2 package rows20190220_3838ecd0-4b5b-4c68-8995-33b5c27718be.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72749-00072749-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
TARTARIC ACIDW4888I119HIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
TURMERIC856YO1Z64FIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

Source Document#

Source XML · Source PDF

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
822e1fe3-ee52-213c-e053-2991aa0a3e353838ecd0-4b5b-4c68-8995-33b5c27718be2019-02-18WarningsExact identifier
spl id: 822e1fe3-ee52-213c-e053-2991aa0a3e35
spl set id: 3838ecd0-4b5b-4c68-8995-33b5c27718be

Reported adverse events (FAERS/openFDA)#

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