FDA.reportPublic FDA data

Pure-Aid Pain Relief Hot Patch

Manufacturer
Kareway Product, Inc.
Effective date
2023-02-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:36:28

Label at a glance#

ProductMedicated Pain Relief Hot
Active ingredientMENTHOL, CAPSAICIN
Label structure8 sections

Indications and uses

Temporarily relieves minor pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle sprains bruises

Dosage and administration

Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily. Children under 12 years of age: Consult a physician.

Storage and handling

store at 20° to 25°C (68°to 77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)

Purposes

OTC - PURPOSE SECTION

Topical analgesic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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 right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68°to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, povidone, propylene glycol, propylparaben, tartaric acid, titanium dioxide, sodium polyacrylate, water

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Hot Patch

Pain Relief Hot PatchPain Relief Hot Patch

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-012667510-0126-2, 67510-0126-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
POVIDONEFZ989GH94EIACT

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
f4eb549f-3dcc-7ab8-e053-2995a90a74c75f52a45d-26c1-1da2-e053-2991aa0a7d492023-02-17WarningsExact identifier
spl id: f4eb549f-3dcc-7ab8-e053-2995a90a74c7
spl set id: 5f52a45d-26c1-1da2-e053-2991aa0a7d49

Reported adverse events (FAERS/openFDA)#

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