Drug Labeling and Warnings

Drug Details

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MEDISTIK ICE- menthol and methyl salicylate stick 
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.

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ACTIVE INGREDIENTS

Menthol 10%

Camphor 4%

PURPOSE

Topical Analgesic

USES

For the temporary relief of sore muscles and joints associated with

  • strains and sprains
  • backaches
  • lumbago
  • pain of tendons and/or ligaments
  • arthritic or rheumatic pain

WARNINGS

For external use only. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

Stop use and consult a physician if condition worsens, rash or irritation develops, or if symptoms persist for more than 7 days or clear up and recur in a few days. Consult a health care practitioner prior to use if you are pregnant or breastfeeding. 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.

Apply to affected area(s) 3 to 4 times per day as required. 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.

INACTIVE INGREDIENTS

Denatured alcohol, Water, Peppermint oil, Glycerin, Acrylates copolymer, MSM, Ilex paraguariensis leaf extract, Glucosamine sulphate, Chondroitin sulphate, Folic acid, Vitamin C, Vitamin D.

Cautions: Keep out of reach of children. If overdose or accidental ingestion occurs, call a Poison Control Center immediately.

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MEDISTIK ICE 
menthol and methyl salicylate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50231-411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
CAMPHOR OIL (UNII: 75IZZ8Y727) (CAMPHOR OIL - UNII:75IZZ8Y727) CAMPHOR OIL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
FOLIC ACID (UNII: 935E97BOY8)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50231-411-1189 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/17/2016
Labeler - Natureteq Inc. (243737371)

Revised: 1/2020
 
Natureteq Inc.


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