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MEDISTIK ICE

Natureteq (as PLD) - MEDISTIK PRO ICE THERAPY (50231-411)

Approved
Approval ID

c1077744-7b9a-4536-8faf-e21994a43ea5

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.

Menthol, Camphor

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50231-411
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol, Camphor
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 15, 2025
FDA Product Classification

INGREDIENTS (14)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 71DD5V995L
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
GLUCOSAMINE SULFATEInactive
Code: 1FW7WLR731
Classification: IACT
CHONDROITIN SULFATE (CHICKEN)Inactive
Code: 7VZ9466BAB
Classification: IACT
FOLIC ACIDInactive
Code: 935E97BOY8
Classification: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
VITAMIN DInactive
Code: 9VU1KI44GP
Classification: IACT
MENTHOLActive
Quantity: 10 g in 100 mL
Code: L7T10EIP3A
Classification: ACTIB
CAMPHOR OILActive
Quantity: 4 g in 100 mL
Code: 75IZZ8Y727
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

![01b LBL_NTQ_Medistik Professional Ice Therapy Roll-on (50231-411)](/dailymed/image.cfm?name=01b+LBL_NTQ_Medistik+Professional+Ice+Therapy+Roll- on+%2850231-411%29.jpg&id=897830)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/17/2016

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 2/17/2016

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/17/2016

ACTIVE INGREDIENTS

Menthol 10%

Camphor 4%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/17/2016

PURPOSE

Topical Analgesic

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/17/2016

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 2/17/2016

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 2/17/2016

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.

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MEDISTIK ICE - FDA Drug Approval Details