Rugby® Ice Blue Gel External Analgesic

Rugby® Ice Blue Gel External Analgesic

Drug Labeling and Warnings

Drug Details

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

  • 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.

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

  • 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

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 gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-1061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Ammonia (UNII: 5138Q19F1X)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
Carboxymethylcellulose Sodium (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 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Not Finalpart34801/20/2015
Labeler - Rugby Laboratories, Inc. (079246066)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.103039178MANUFACTURE(0536-1061)

Revised: 2/2015
 
Rugby Laboratories, Inc.


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