Medistik Ice

Manufacturer
Natureteq Inc.
Effective date
2025-09-15
Label type
HUMAN OTC DRUG LABEL
Version
17
Source
full-release
Hydrated at
2026-06-01 01:13:51

Label at a glance#

ProductMEDISTIK ICE
Active ingredientMENTHOL, CAMPHOR OIL
Label structure8 sections

Indications and 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

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Camphor 4%

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

USES

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_NTQ_Medistik Professional Ice Therapy Roll-on (50231-411)01b LBL_NTQ_Medistik Professional Ice Therapy Roll-on (50231-411)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2370887camphor 4 % / menthol 10 % Topical SolutionPSN17
2370887camphor 40 MG/ML / menthol 100 MG/ML Topical SolutionSCD17
2370887camphor 4 % / menthol 10 % Topical SolutionSY17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50231-411-11MEDISTIK ICE89 mL in 1 BOTTLESOLUTION8917
50231-411-12MEDISTIK ICE500 mL in 1 BOTTLESOLUTION50017

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50231-41150231-411-11, 50231-411-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
ndc (package): 50231-411-11
ndc (package): 50231-411-12
ndc (product): 50231-411
ndc11 (package): 50231041112
ndc11 (package): 50231041111
spl id: 3edd5b1a-c3cf-76fd-e063-6294a90a8f10
spl set id: c1077744-7b9a-4536-8faf-e21994a43ea5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.