Theracare Ice Blue Gel
FDA Label NDC 71101-217

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Ice Blue Gel (NDC 71101-217). 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, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 2%

Purpose

Topical analgesic

Uses

● temporarily relieves minor aches and pains of muscles and joints associated with:

● simple backache

● arthritis

● strains

● bruises

● sprains

Warnings

For external use only

When Using This Product

  • with other topical pain relievers
  • with heating pads or heating devices
  • avoid contact with eyes
  • do not bandage tightly
  • do not apply to wounds or damage skin

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days or clear up 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 (800-222-1222) right away.

Directions

  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor before using this product

Other Information

  • do not freeze
  • store at room temperature
  • keep container tightly closed when not in use
  • do not use, pour, spill, or store near heat or open flame

Inactive Ingredients

ammonium hydroxide, benzyl alcohol, carbopor 940, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, PEG-40 hydrogenated castor oil, sodium hydroxide, thymol, water

Questions Or Comments?

Customer care 866-326-1313

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