Wish Ultra Winter Ice Gel
FDA Label NDC 84809-008

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lj Pharma for the product Wish Ultra Winter Ice (NDC 84809-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient                                   purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                   Purpose

Menthol 2%                                          Topical analgesic

Uses

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

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

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.

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

Other Information

  • store at 20° - 25°C ( 68° - 77° F) [ see USP Controlled Room Temperature], in a tightly closed container
  • store in a cool place 
  • do not use, pour, spill or store near heat or open flame 

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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