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MEDISTIK DUAL HOT AND COLD

Natureteq (as PLD) - MEDISTIK DUAL ACTION (50231-511)

Approved
Approval ID

ba5f4626-f077-4a28-8dcc-dacd50741ead

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 15, 2025

Manufacturers
FDA

Natureteq Inc.

DUNS: 243737371

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Methyl Salicylate, Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50231-511
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Methyl Salicylate, Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (8)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BOSWELLIA SERRATA WHOLEInactive
Code: X7B7P649WQ
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
GLUCOSAMINE SULFATEInactive
Code: 1FW7WLR731
Classification: IACT
CHONDROITIN SULFATE (CHICKEN)Inactive
Code: 7VZ9466BAB
Classification: IACT
MENTHOLActive
Quantity: 10 g in 100 mL
Code: L7T10EIP3A
Classification: ACTIB
METHYL SALICYLATEActive
Quantity: 12 g in 100 mL
Code: LAV5U5022Y
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 3/19/2020

Principal panel

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/19/2016

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/18/2020

ACTIVE INGREDIENTS

Methyl Salicylate 12%

Menthol 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/19/2016

PURPOSE

Topical Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 2/19/2016

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/19/2016

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 2/19/2016

INACTIVE INGREDIENTS

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/19/2016

KEEP OUT OF REACH OF CHILDREN

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