MedPath

Mountain Ice

Mountain Ice Pain Relief Gel

Approved
Approval ID

c79fdd91-16f4-4ae0-bee4-d37c05ed2074

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 28, 2025

Manufacturers
FDA

Mountainside Medical Equipment, Inc.

DUNS: 119735871

Products 1

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

Menthol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72793-100
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 28, 2025
FDA Product Classification

INGREDIENTS (21)

ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CAMPHOR OILInactive
Code: 75IZZ8Y727
Classification: IACT
TURMERIC OILInactive
Code: 6KGS8SP16U
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
GLUCOSAMINE HYDROCHLORIDEInactive
Code: 750W5330FY
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ILEX PARAGUARIENSIS LEAFInactive
Code: 1Q953B4O4F
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
TEA TREE OILInactive
Code: VIF565UC2G
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MENTHOL, UNSPECIFIED FORMActive
Quantity: 5 g in 100 mL
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/3/2019

Package/Label Principal Display Panel – Tube Label

Arthritis Pain Relieving Gel

MOUNTAIN ICE

Tumeric, Glucosamine, Chondroitin, Methylsulfonylmethane (MSM), Camphor, Menthol 5%, Arnica Montana, Aloe Vera, Tea Tree Oil, Hyaluronic acid, Vitamin E, Ilex Paraguariensis Leaf Extract.

4 fl oz (118 mL)

Label Mountain Ice

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/3/2019

Uses

Temporary relief of minor aches and pains of muscles and joints associated with osteoarthritis, rheumatoid arthritis, muscle strains, and sprains

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/3/2019

Active ingredients:

Menthol 5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/3/2019

Purpose

External Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 6/3/2019

Warnings

For external use only.

Flammable; keep away from excessive heat or open flame. Avoid contact with eyes or mucous membranes.

When using this product:

  • Do not apply to wounds, damaged skin, or irritated skin.
  • Do not apply with other creams, ointments, sprays or liniments.
  • Stop use and ask a doctor if: Conditions worsen, skin irritation develops, or condition does not improve after 7 days.

Keep out the reach of children:

If accidentally swallowed seek medical attention immediately or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/3/2019

Directions:

Adults and Children 2 years of age or older: Rub on the affected area evenly no more than 4 time. Children under 2 years of age: Consult with your doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/23/2020

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Flower Extract, Carbomer, Cinnamomum Camphora (Camphor) Bark Oil, Curcuma longa (Turmeric) Root Oil, Dimethyl Sulfone, Ethylhexylglycerin, Glucosamine HCl, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Limonene, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Phenoxyethanol, Polysorbate 20, Propanediol, Sodium Chondroitin Sulfate, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water (Aqua), Blue 1 (CI 42090).

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