FDA.reportPublic FDA data

Pure-Aid Pain Relievng Gel Roll-On

Manufacturer
KAREWAY PRODUCT, INC.
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:38:55

Label at a glance#

ProductPain Reliving Roll-on
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician wash hands after use with cool water

Storage and handling

store at 20-25°C (68-77°F) store in a cool dry place away from direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

Purpose

OTC - PURPOSE SECTION

Pain Relieving Gel

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from excessive heat or open flame

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis (Green Tea) Leaf Extract, Camphor, Carbomer, Centella Asiatica Extract, Ethylhexylglycerin, FD&C Blue No.1, FD&C Yellow No.5, IIex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate, Trolamine, Water

SPL UNCLASSIFIED SECTION

Exclusively distributed by:

Kareway Product, Inc.

Compton, CA 90220

www.kareway.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-067367510-0673-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CAMPHOR OIL75IZZ8Y727IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOMER 9404Q93RCW27EIACT
CENTELLA ASIATICA7M867G6T1UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL ALCOHOLND2M416302IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

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
f3093a16-5ed9-19eb-e053-2995a90a22bcf3093a16-5ed8-19eb-e053-2995a90a22bc2023-01-24WarningsExact identifier
spl id: f3093a16-5ed9-19eb-e053-2995a90a22bc
spl set id: f3093a16-5ed8-19eb-e053-2995a90a22bc

Reported adverse events (FAERS/openFDA)#

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