Equaline Blue Ice Pain Relieving
FDA Label NDC 41163-488

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Supervalu Inc for the product Equaline Blue Ice Pain Relieving (NDC 41163-488). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, inactive ingredient, 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 2.0% ..........................................................................Topical Analgesic

Otc - Purpose

Uses: Temporary relief of minor aches and pains in: Muscles and joints.

Warnings

Warnings:

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

Otc - When Using

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.

Otc - Stop Use

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Indications & Usage

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 and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily

Inactive Ingredient

Inactive Ingredients: Aqua (water), Isopropyl Alcohol, Carbomer, Thymol, Ammonium Hydroxide, Sodium Hydroxide, Magnesium Sulfate, FD and C Blue No.1

Dosage & Administration

DISTRIBUTED BY SUPERVALU INC.

EDEN PRAIRIE, MN 55344 USA

MADE IN CANADA

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