Meijer Cold Therapy Pain Relieving Gel
FDA Label NDC 79481-0087

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution, Inc for the product Meijer Cold Therapy Pain Relieving (NDC 79481-0087). 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 other, active ingredient, purpose, uses, warnings, otc - ask doctor, when using this product, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Flammable

  • ⬥keep away from fire or flame.

    • DIST. BY MEIJER DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544

Active Ingredient

Menthol 4%

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Otc - Ask Doctor

Ask a doctor before use if you have sensitive skin.

When Using This Product

  • ⬥Avoid contact with the eyes
  • ⬥Do not apply to wounds or damaged skin
  • ⬥Do not use with other ointments, creams, sprays or liniments
  • ⬥Do not apply to irritated skin or if excessive irritation develops
  • ⬥Do not bandage tightly
  • ⬥Wash hands after use with cool water
  • ⬥Do not use with heating pads or heating devices.

Stop Use And Consult A Doctor If

  • ⬥condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • ⬥Adults and children 6 years of age and older: Apply to affected area not more than 3-4 times daily. Massage not necessary
  • ⬥Children under 6 years of age: Do Not Use.

Storage And Handling

Other information store in a cool dry place with lid closed tightly.

Inactive Ingredient

Inactive ingredients aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.

Otc - Questions

Questions or comments? 1-866-567-8600

Principal Display Panel - 89 Ml Tube Label

NDC 79481-0087-1

meijer®

Cold Therapy
Pain Relieving
Gel

COMPARE TO
BIOFREEZE®
PAIN RELIEF GEL
ACTIVE INGREDIENT*

MENTHOL 4% |
TOPICAL ANALGESIC

For backache, muscle
pain, joint pain

Cooling menthol

3 FL OZ (89 mL)

Principal Display Panel (89 mL Tube Label)

Principal Display Panel (89 mL Tube Label)

* Please review the disclaimer below.