MEDISTIK DUAL HOT AND COLD- methyl salicylate, menthol spray

Medistik Dual Hot and Cold by

Drug Labeling and Warnings

Medistik Dual Hot and Cold by is a Otc medication manufactured, distributed, or labeled by Natureteq Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Methyl Salicylate-12% w/w

Mentha Haplocalyx Briq (Menthol)-10%w/w

PURPOSE

Topical Analgesic

USES

Provides temporary soothing relief of sore muscles associated with strains and sprains, backaches, lumbago, pain of tendons
and/or ligaments as well as arthritic or rheumatic pain

WARNINGS

For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not inhale. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn. Keep out of the reach of children. If overdose or accidental ingestion occurs, call a Poison Control Center immediately. Consult your health care practitioner prior to use if you are pregnant or breastfeeding or if you are taking anti-coagulant medications or if you are taking medication or natural health products that cause dilation of blood vessels. Rashes and/or burning discomfort and hypersensitivity such as allergy have been known to occur; in which case; discontinue use.

DIRECTIONS

For use on adults and children over 12 years of age. For children (12 years old): Application should be supervised by an adult. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. A stinging or burning sensation will be experienced during the first few minutes as the formula begins working. For arthritis or muscle pain of the hands, retain for at least 10 minutes then wash hands. Consult your health care practitioner for use beyond 7 days

INACTIVE INGREDIENTS

Isopropyl alcohol, Water, MSM, Boswellia serrata extract, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDISTIK DUAL HOT AND COLD 
methyl salicylate, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50231-511
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	12 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50231-511-11	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/19/2016

Labeler - Natureteq Inc. (243737371)