Arctic Ice Pain Relieving Gel
FDA Label NDC 87510-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Onest Limited for the product Arctic Ice Pain Relieving Gel (NDC 87510-006). 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, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient            Purpose

Menthol, 1.25%        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 a cough associated with:
  • Smoking
  • Excessive phlegm
  • Asthma
  • Emphysema
  • Persistent or chronic cough

    • When using this product, do not:

    • Heat, microwave, or 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 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

Water, Ethyl Alcohol, Carbomer, Camphor, Sodium Hydroxide, FD&C Blue 1, Methylchloroisothiazolinone, Methylisothiazolinone

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