Ice Analgesic
FDA Label NDC 50438-501

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Ice Analgesic (NDC 50438-501). 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, when using this product do not, consult a doctor and discontinue use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 1.0%

Purpose

Topical Analgesic

Uses

Temporary relief:

minor muscles aches and pains

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 by mouth or place in nostrils
  • apply to wounds or damaged skin
  • bandage skin

Consult A Doctor And Discontinue Use

if condition worsens, persist for more than 1 week or tends to recur

Keep Out Of Reach Of Children.

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

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 and children 2 years of age and older: apply to painful area and massage until gel is absorbed into the skin, repeat 3 to 4 times daily

Inactive Ingredients

blue 1, camphor, carbomer, isopropyl alcohol, methylchoroisothiazolinone, methuylisothiazoline, sodium hydroxide, water

Package Label.Principal Display Panel

ICE Analgesic Gel

Net wt 8oz (227g)

DISTRIBUTED BY:

Filo America

P.O. Box 23592

Los  Angeles, CA 90023

Developed in USA, products in PRC

questions or concerns?

1.866.460.0322

* Please review the disclaimer below.