RUGBY ICE BLUE  EXTERNAL ANALGESIC- menthol, unspecified form gel 
Rugby Laboratories, Inc.

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Rugby® Ice Blue Gel
External Analgesic

Drug Facts

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

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.

If pregnant or breast-feeding ask a health professional before use.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

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

Questions or comments?

1-800-645-2158

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

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
RUGBY ICE BLUE   EXTERNAL ANALGESIC
menthol, unspecified form gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Ammonia (UNII: 5138Q19F1X)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Cupric Sulfate (UNII: LRX7AJ16DT)  
Isopropyl Alcohol (UNII: ND2M416302)  
Magnesium Sulfate Anhydrous (UNII: ML30MJ2U7I)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Thymol (UNII: 3J50XA376E)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1061-39226.8 g in 1 JAR; Type 0: Not a Combination Product01/20/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/20/2015
Labeler - Rugby Laboratories, Inc. (079246066)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.036464697MANUFACTURE(0536-1061)

Revised: 3/2024
Document Id: 1c88e8a5-94ce-415d-8d12-0879b179c6a4
Set id: 2b65cb6a-4364-4770-b7b9-5c4637edd01a
Version: 4
Effective Time: 20240314
 
Rugby Laboratories, Inc.