MedPath

Wish ultra winter ice

Approved
Approval ID

b4c5487c-1314-4d63-96df-077e72e7ee95

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

LJ Pharma

DUNS: 914078633

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 Code84809-008
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (10)

AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CUPRIC SULFATEInactive
Code: LRX7AJ16DT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMInactive
Code: DE08037SAB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
THYMOLInactive
Code: 3J50XA376E
Classification: IACT
MENTHOL, UNSPECIFIED FORMActive
Quantity: 2 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/28/2025

Product label

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/28/2025

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
  • Provides cooling relief

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/28/2025

Active Ingredient Purpose

Menthol 2% Topical analgesic

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/28/2025

WARNINGS SECTION

LOINC: 34071-1Updated: 7/28/2025

Warnings

For external use only

Do not use:

  • With other topical pain relievers
  • With heating pads or heating devices

Stop use and ask a doctor if:

  • Condition worsens
  • Symptoms last more than 7 days and/or subside and occur again within a few days

If pregnant or breast-feeding: Ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/28/2025

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/28/2025

Directions

  • Clean affected area before applying product
  • Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: Ask a doctor

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/28/2025

Questions or Comments? 1-888-402-0184

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/28/2025

Inactive Ingredients

Ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

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Wish ultra winter ice - FDA Drug Approval Details