Active Ingredient:
Menthol, 1.25%
Arctic Ice Gel
FDA Label NDC 80801-105
9 label sections · Submitted to the FDA by Primal Elements · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Primal Elements for the product Arctic Ice (NDC 80801-105). 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, do not:, consult a doctor and discontinue use:, keep out of reach of children., directions:, 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 muscle aches and pains
Warnings:
For external use only; avoid contact with eyes.
Ask a doctor before use if you have cough associated with smoking, excessive phlegm, asthma, emphysema, persistent or chronic cough.
When Using This Product, Do Not:
heat
microwave
add to hot water or any container where heating water may cause splattering and result in burns
use in eyes or directly on mucous membranes
take by mouth or place in nostrils
apply to wounds or damaged skin
bandage skin
Consult A Doctor And Discontinue Use:
if condition worsens, persists for more than 1 week or tends to recur.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions:
For the temporary relief of minor muscle aches and pains.
See important warnings under "When using this product"
- not for use on children under 2 years of age
- adults & children 2 years & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 times daily.
Inactive Ingredients:
Blue 1, Camphor, Carbomer, Ethyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water.
* Please review the disclaimer below.
