MEDISTIK DUAL HOT AND COLD: Package Insert and Label Information

MEDISTIK DUAL HOT AND COLD- menthol and methyl salicylate spray
Natureteq 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.

ACTIVE INGREDIENTS

Methyl Salicylate 12%

Menthol 10%

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

Medistick Pro Dual Action Spray
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 12 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
WATER
BOSWELLIA SERRATA WHOLE
ILEX PARAGUARIENSIS LEAF
GLUCOSAMINE SULFATE
CHONDROITIN SULFATE (CHICKEN)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50231-511-11 118 mL in 1 BOTTLE None
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)

Revised: 11/2021 Natureteq Inc.

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