Active Ingredient
Menthol 2.0%
Blue Ice Analgesic Gel
FDA Label NDC 61734-021
Full FDA labeling including 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, otc - keep out of reach of children, inactive ingredients, directions, delon 8oz (227g), 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:
- Minor aches and pains of muscles and joints
Warnings
For external use only; avoid contact with eyes and mucous membranes.
When using this product, do not:
- heat
- microwave
- add to hot water or any container where heating water
- use with other creams, sprays or liniments
- apply to damaged skin or wounds
- Bandage area tightly
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- skin irritation develops
- hypersensitivity develops
May result in excessive skin irritation or skin burns
Stop use and ask a physician if
If pregnant or breast-feeding, ask a health professional before use.
if you have sensitive skin, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Aqua (Water), Isopropyl Alcohol, Carbomer, Thymol, Ammonium Hydroxide, Sodium Hydroxide, Magnesium Sulfate, FD&C Blue No. 1.
Directions
- see important warnings under "When using this product"
- adults and children 2 years of age and older:
- apply liberally to painful area and massage until gel is absorbed
- use up to 3-4 times daily or as directed by a doctor
- children under 2 years of age:
- do not use, unless advised by a physician
Delon 8Oz (227G)
* Please review the disclaimer below.
