Icequake Coldn Hot Medicated Patch Cloth
FDA Label NDC 69822-014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Icequake Coldn Hot Medicated Patch (NDC 69822-014). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, do not use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with: • arthritis • muscle strains • simple backache • bursitis • cramps • tendonitis • muscle sprains • bruises

Warnings

For external use only

When Using This Product

  • use only as directed 
  • do not bandage tightly 
  • do not use a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Do Not Use

  • if you are allergic to any ingredients of this product

Stop Use And Ask A Doctor If

  • condition worsens 
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present 
  • irritation develops

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep Out Of Reach Of Children.

If swallowed, get medical help or conctact a Poison Control Center right away

Directions

Adults and children over 12 years:

  • Carefully remove backing film from patch
  • Apply one patch to affected area
  • Use one patch at a time, 1 or 2 times a day

    • Children under 12 years of age:store at room temperature

Other Information

store at room temperature

Inactive Ingredients

CARBOXYMETHYLCELLULOSE, DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, POLYACRYLIC ACID , PROPYLENE GLYCOL, POLYSORBATE 80, POVIDONE, PROPYLPARABEN, SODIUM POLYACRYLATE, TARTARIC ACID, TITANIUM DIOXIDE, WATER

Package Labeling:

Rl1 (Revisedlabel)

Rl1 (Revisedlabel)

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