FDA.reportPublic FDA data

TENHEALER Pain Rub

Manufacturer
BIO HEALING THERAPY INDUSTRIES INC | ATS HEALTH AND BEAUTY CARE CORPORATION
Effective date
2019-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:11:38

Label at a glance#

ProductTENHEALER Pain Rub
Active ingredientDIMETHYL SULFONE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure11 sections

Indications and uses

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

Dosage and administration

use only as directed adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Storage and handling

store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients...................................Purpose
Camphor 5% .........................................Topical analgesic
Menthol 5% ...........................................Topical analgesic
Methyl salicylate 15% ...........................Topical analgesic
Methylsulfonylmethane (MSM) 1.5% ....Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have redness over the affected area.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic capric/triglycerides, carbomer, cetearyl alcohol, cyclomethicone, glycerin, ceteareth-20, iodopropynyl butylcarbamate, isopropyl myristate, phenoxyethanol, polysorbate 80, sodium hydroxide, water

Questions?

OTC - QUESTIONS SECTION

1-833-583-3079

SPL UNCLASSIFIED SECTION

Bio Healing Therapy Industries Inc.
191 Rowntree Dairy Rd Woodbridge, ON L4L 8B8
www.BioHealingTherapy.com

Purpose

OTC - PURPOSE SECTION

Active ingredients...................................Purpose
Camphor 5% .........................................Topical analgesic
Menthol 5% ...........................................Topical analgesic
Methyl salicylate 15% ...........................Topical analgesic
Methylsulfonylmethane (MSM) 1.5% ....Topical analgesic

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Rub Lotion

125 mL125 mL

250 mL250 mL

500 mL500 mL

1000 mL1000 mL

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71096-11171096-111-01, 71096-111-02, 71096-111-03, 71096-111-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFONE9H4PO4Z4FTACTIB
CYCLOMETHICONENMQ347994ZIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
LANOLIN7EV65EAW6HIACT
POLYSORBATE 806OZP39ZG8HIACT
OCTYL CAPRATEVX4042MLV4IACT
WATER059QF0KO0RIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
ca7fd689-6e32-1e4f-e053-2995a90a1ed79233f533-ea7e-6da1-e053-2a95a90a115f2021-08-26WarningsExact identifier
spl set id: 9233f533-ea7e-6da1-e053-2a95a90a115f

Reported adverse events (FAERS/openFDA)#

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