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Medistik Dual Hot and Cold

Dosage form: spray
Ingredients: MENTHOL 10g in 100mL, METHYL SALICYLATE 12g in 100mL
Labeler: Natureteq Inc.
NDC Code: 50231-511

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% 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

MEDISTIK DUAL HOT AND COLD 
methyl salicylate, menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50231-511
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
BOSWELLIA SERRATA WHOLE 
ILEX PARAGUARIENSIS LEAF 
GLUCOSAMINE SULFATE 
CHONDROITIN SULFATE (CHICKEN) 
Packaging
#Item CodePackage Description
1NDC:50231-511-11118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2016
Labeler - Natureteq Inc. (243737371)

Revised: 02/2016
 
Natureteq Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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