TENHEALER PAIN RUB- camphor (synthetic), menthol, methyl salicylate lotion 
BIO HEALING THERAPY INDUSTRIES INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TENHEALER® Pain Rub

Drug Facts

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

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

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

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

When using this product

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

Stop use and ask a doctor if

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

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

Directions

  • 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

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

Inactive ingredients

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

Questions?

1-833-583-3079

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

Purpose

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

Pain Rub Lotion

125 mL

250 mL

500 mL

1000 mL

TENHEALER PAIN RUB 
camphor (synthetic), menthol, methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71096-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)50 mg  in 1 mL
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT) DIMETHYL SULFONE15 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
OCTYL CAPRATE (UNII: VX4042MLV4)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71096-111-011 in 1 PACKAGE08/01/201912/31/2020
1125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:71096-111-021 in 1 PACKAGE08/01/201912/31/2020
2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:71096-111-031 in 1 PACKAGE08/01/201912/31/2020
3500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:71096-111-041 in 1 PACKAGE08/01/201912/31/2020
41000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/201912/31/2020
Labeler - BIO HEALING THERAPY INDUSTRIES INC (203468038)
Registrant - ATS HEALTH AND BEAUTY CARE CORPORATION (241590277)
Establishment
NameAddressID/FEIBusiness Operations
ATS HEALTH AND BEAUTY CARE CORPORATION241590277manufacture(71096-111)

Revised: 8/2021
Document Id: ca7fd689-6e32-1e4f-e053-2995a90a1ed7
Set id: 9233f533-ea7e-6da1-e053-2a95a90a115f
Version: 2
Effective Time: 20210826
 
BIO HEALING THERAPY INDUSTRIES INC