Blue Ice Analgesic Gel
FDA Label NDC 15127-452

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Brand Distributors for the product Blue Ice Analgesic Gel (NDC 15127-452). 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, uses, directions, warnings, package label.principal display panel, purpose, inactive ingredients, 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

Active Ingredient


Menthol 2.0%

Uses

  • Temporary relief of minor aches and pains in: muscles and joints.

Directions

Directions:

  • See important warnings under ''When Using This Product''.
  • Do not apply to children under 2 years of age, unless advised by a physician.
  • Adults and children over 2 years of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.

Warnings

  • For external use only.
  • Avoid contact with eyes and mucus membranes.

    • When using this product, do not:

    • use with heating pads or heating devices
    • use, pour, spill or store near open flame
    • use with other creams, sprays or liniments
    • apply to damaged skin or wounds
    • bandage area tightly

      • To do so may result in excessive skin irritation or skin burn.

      If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

Package Label.Principal Display Panel

Sb Blue Ice Gel (Selectbrandblueicegel)

Sb Blue Ice Gel (Selectbrandblueicegel)

Purpose

  • Analgesic.

Inactive Ingredients

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep Out Of Reach Of Children

  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

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