Arctic Ice Analgesic
FDA Label NDC 22431-600

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blue Cross Labs for the product Arctic Ice Analgesic (NDC 22431-600). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:               Purpose

Menthol, 1%  .................. Topical analgesic

Otc - Purpose

Uses: temporarily relieves:

  • minor muscle aches and pains

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Indications & Usage

Consult a doctor and discontinue use;

if conditon worsens, persists for more than 1 week or tends to recur

Warnings

Warnings: For external use only; avoid contact with eyes. Ask a doctor before use if you have associated with

  • smoking
  • excessive phlegm
  • asthma
  • emphysema
  • persisten or chronic cough

    • When using this product, do; heat

    • microwave
    • add to hot water or any container where healing water may cause splatter 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

Dosage & Administration

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 year & older: Apply liberally to painful area and massage until gel is absorbed into the skin. Repeat 3 to 4 time daily.

Inactive Ingredient

Blue 1, Camphor, Carbomer, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide, Water.

Package Label.Principal Display Panel

Arctic Ice

Analgesic Gel

NET WT. 8 OZ. (227)

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