Arctic Relief Gel
FDA Label NDC 58980-615

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Arctic Relief (NDC 58980-615). 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 other, active ingredient, purpose, inactive ingredients, uses, warnings, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

Active Ingredient

Natural Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Inactive Ingredients

Camphor, carbomer, FD&C blue #1, FD&C yellow #5, herbal extract, isopropyl alcohol, methyl paraben, silicon dioxide, trolamine and purified water.

Uses

Temporary relief from minor aches and pains of sore muscles & joints associated with

  • arthritis
  • backache
  • strains
  • sprains.

Warnings

FOR EXTERNAL USE ONLY.

Flammable: Keep away from excessive heat or open flame.

Otc - Ask Doctor

Ask a doctor before use if you have sensitive skin.

When Using This Product

  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with a heating pad or device.

Stop Use And Ask A Doctor If

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur.

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
  • Children under 2 years of age: Consult physician

Other Information

Store in a cool dry place with cap closed tightly

Questions Or Comments?

Call Customer Service at 800-442-7882

Principal Display Panel - 113.4 Gram Tube Box

Arctic Relief
PAIN RELIEVING GEL

NDC 58980-615-40

Net WT. 4 oz. / 113.4 grams

•GREASELESS •STAINLESS •VANISHING SCENT

PENETRATING, LONG-LASTING PAIN RELIEF FROM:
ARTHRITIS, SORE MUSCLES & JOINTS AND BACK PAIN.

STRATUS
PHARMACEUTICALS INC

Principal Display Panel (113.4 gram Tube Box)

Principal Display Panel (113.4 gram Tube Box)

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