Ice Cold Analgesic
FDA Label NDC 58503-087

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by China Ningbo Shangge Cosmetic Technology Corp. for the product Ice Cold Analgesic (NDC 58503-087). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, dosage & administration, warnings, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredient                   Purpose

Menthol 1.0% ............. Topical Analgesic

Otc - Purpose

Uses temporarily relieves:

  • minor muscle aches and pains

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Indications & Usage

DT for your DailyTouch

Ice Cold Analgesic Gel

Gel Frio Antimuscular

Dosage & Administration

Directions

For the temporary relief of minor muscle aches and pains.

See important warnings under "When using this product"

  • not for use on children under 2 years of age
  • adults & children 2 years & older: apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.

Warnings

Warnings

For external use only; avoid contact with eyes.

Ask a doctor before use if you have cough associated with 

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persistent or chronic cough
  • When using this product,do not:

    • heat
    • microwave
    • add to hot water or any container where healing water may cause splattering and result in burns
    • use in eyes or directly on mucous membranes
    • take my mouth or place in nostrils
    • apply to wounds or damaged skin
    • bandage skin
    • Consult a doctor and discontinue use: if condition worsens, persists for more than 1 week or tends to recur.

Inactive Ingredient

Inactive Ingredients

camphor, carbomer, FD&C blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

Package Label.Principal Display Panel

Image Description (Label)

Image Description (Label)

* Please review the disclaimer below.