Warnings
For External Use Only.
Icequake Cold Hot
FDA Label NDC 69822-010
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 Cold Hot (NDC 69822-010). 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 warnings, active ingredient, inactive ingredient, indications & usage, dosage & administration, purpose, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic
Inactive Ingredient
Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide
Indications & Usage
Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis<br />■ muscle strains ■ muscle sprains ■ bruises ■ cramps
Dosage & Administration
Adults and children 12 years of age and over: Carefully remove backing from patch.
Apply one patch to affected area
Repeat as necessary, but no more than 4 times daily.
Children under 12 years of age: Ask a doctor.
Purpose
Topical Analgesic
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.
■ Don’t apply to wounds or damaged skin.
■ Do not use if you are alergic to any ingredients of this product.
Stop Use And Ask A Doctor
■ If condition worsens
■ If symptoms persist for more than 7 days or clear up and occur again within a few days.
■ If redness is present
■ If irritation develops
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breastfeeding
ask a health professional before use.
* Please review the disclaimer below.
