Active Ingredient
Menthol 2.0%
Blue Ice Analgesic Gel
FDA Label NDC 61734-021
10 label sections · Submitted to the FDA by Delon Laboratories (1990) Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Delon Laboratories (1990) Ltd for the product Blue Ice Analgesic (NDC 61734-021). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - 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
- for the temporary relief of minor aches and pains of muscles and joints
Warnings
For external use only
When Using This Product
- avoid contact with the eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
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
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 right away.
Directions
- 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: consult a doctor
Inactive Ingredients
ammonium hydroxide, carbomer, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water
* Please review the disclaimer below.
