Equate Cold Therapy Pain Relieving Gel
FDA Label NDC 79903-021

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Equate Cold Therapy Pain Relieving (NDC 79903-021). 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, when using this product, otc - stop use, flammable, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

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

When Using This Product

  • ⬥avoid contact with eyes
  • ⬥do not apply to wounds or damaged skin
  • ⬥do not bandage tightly
  • ⬥do not use with heating pads or other heating devices

Otc - Stop Use

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.

Flammable

  • ⬥keep away from fire or flame

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, 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. Children under 6 years of age: Do Not Use.

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.

Questions Or Comments?

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Principal Display Panel - 89 Ml Tube Label

NDC 79903-021-01

equate™

Compare
to Biofreeze®
active
ingredient*

Cold Therapy
Pain Relieving
Gel

Menthol 4% Topical
Analgesic

  • For backache, muscle
    pain, joint pain
  • Soothing menthol

    • 3 FL OZ (89mL)

    Principal Display Panel (89 mL Tube Label)

    Principal Display Panel (89 mL Tube Label)

* Please review the disclaimer below.