Active Ingredient
Menthol 1.25%
Ice Gel
FDA Label NDC 52000-220
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Ice Gel (NDC 52000-220). 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, do not use, when using this product, stop use and ask a doctor if, 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
Purpose
Topical Analgesic
Uses
■ temporarily relieves minoraches and pains of muscles and joints associated with:
■ arthritis ■ simple backache ■ strains ■ bruises ■ sports injuries ■ sprains ■ provides cooling penetrating relief
Warnings
For external use only
Do Not Use
■ with other topical relievers ■ with heating pads or heating devices
When Using This Product
■ do not use in or near the eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly
Stop Use And Ask A Doctor If
■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days ■ redness or irritation develops
Keep Out Of Reach Of Children
If pregnant or breast-feeding,ask a health professional before use. If swallowed, get medical help or contact a Poison Control Center 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
Other Information
■ stroe at controlled room temperature 20 to 25 °C (68 to 77°F) in a tightly closed container ■ do not use, pour, spill or store near heat or open flame
Inactive Ingredients
benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no. 1, isopropyl alcohol, PEG-40 hydrogenated castor oi, propylene glycol, sodium hydroxide, water
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