TENHEALER PAIN RUB (camphor- synthetic, menthol, methyl salicylate lotion

TENHEALER Pain Rub by

Drug Labeling and Warnings

TENHEALER Pain Rub by is a Otc medication manufactured, distributed, or labeled by BIO HEALING THERAPY INDUSTRIES INC, ATS HEALTH AND BEAUTY CARE CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

TENHEALER PAIN RUB 
camphor (synthetic), menthol, methyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71096-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) (DIMETHYL SULFONE - UNII:9H4PO4Z4FT)	DIMETHYL SULFONE	15 mg  in 1 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	50 mg  in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	50 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LANOLIN (UNII: 7EV65EAW6H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
OCTYL CAPRATE (UNII: VX4042MLV4)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71096-111-01	1 in 1 PACKAGE	08/01/2019
1		125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 71096-111-02	1 in 1 PACKAGE	08/01/2019
2		250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 71096-111-03	1 in 1 PACKAGE	08/01/2019
3		500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 71096-111-04	1 in 1 PACKAGE	08/01/2019
4		1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2019

Labeler - BIO HEALING THERAPY INDUSTRIES INC (203468038)

Registrant - ATS HEALTH AND BEAUTY CARE CORPORATION (241590277)

Establishment
Name	Address	ID/FEI	Business Operations
ATS HEALTH AND BEAUTY CARE CORPORATION		241590277	manufacture(71096-111)