Rugby Ice Blue Gel
FDA Label NDC 0536-1061

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Ice Blue (NDC 0536-1061). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

Active Ingredient

Menthol 2.0%

Purpose

Pain relieving gel

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do Not Use

  • with other topical pain relievers.
  • with heating pads or other heating devices.

When Using This Product

  • do not use in or near the eyes.
  • do not apply to wounds or damaged skin.
  • do not bandage tightly.

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • redness or irritation develops.

Otc - Pregnancy Or Breast Feeding

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 swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Clean affected area before applying product.
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: do not use, consult a doctor.

Other Information

  • store at room temperature 20 to 25°C (68 to 77°F)
  • Keep lid tightly closed.
  • Do not use, pour, spill or store near heat or open flame.

Inactive Ingredients

ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water

Questions Or Comments?

1-800-645-2158

Principal Display Panel - 226.8 G Jar Label

Rugby® NDC 0536-1061-39

Blue Gel
External Analgesic
Pain Relieving Gel for Minor
Aches and Pains of Muscles
and Joints

COMPARE TO ACTIVE INGREDIENT
IN MINERAL ICE®*

NET WT 8 OZ
(226.8 g)

Principal Display Panel (226.8 g Jar Label)

Principal Display Panel (226.8 g Jar Label)

* Please review the disclaimer below.