Active Ingredient
Menthol 2%
Rexall Ice Cold Analgesic
FDA Label NDC 55910-088
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc for the product Rexall Ice Cold Analgesic (NDC 55910-088). 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, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
For the temporary relief of monor aches and pains in muscles and joints associated with:
■ simple backache
■ sprains
■ arthritis
■ strains
■ sports injuries
■ bruises
Warnings
For external use only
Do Not Use
■ with other topical pain relievers
■ with heating pads or heating devices
When Using This Product
■ do not use in or near eyes ■ do not apply to wounds or damaged skin ■ do not bandage tightly
Stop Use And Ask A Doctor If
■ condition worsens ■ symptoms last for more than 7 days or clear up and occur again within a few days ■ redness or irritation develops
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
Keep out of reach of children and pets. 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
Inactive Ingredients
ammonium hydroxide, carbomer, cupric sulphate, FD&C blue no. 1, isopropyl alcohol, magnesium sulphate, sodium hydroxide, thymol, water
Package Label
Package Label (Icecoldgellbl)
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