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Rugby Pain Relieving Analgesic

Dosage form: cream
Ingredients: MENTHOL, UNSPECIFIED FORM 10mg in 1mL, Methyl Salicylate 150mg in 1mL
Labeler: Rugby Laboratories
NDC Code: 0536-1101

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.

Rugby® Pain Relieving Cream
Topical Analgesic

Drug Facts

Active ingredientsPurpose
Menthol 1.0%Topical Analgesic
Methyl Salicylate 15.0%Topical Analgesic

Use

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

arthritis
simple backache
strains
sprains

Warnings

For external use only

Do not use
immediately after shower or bath
with a heating pad
on wounds, damaged, broken or irritated skin

When using this product
use only as directed
do not swallow
do not bandage tightly
avoid contact with eyes and mucous membranes

Stop and ask a doctor if
skin redness or irritation develops
condition worsens or pain lasts for more than 7 days

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 right away.

Directions
adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily
children under 12 years: ask a doctor.

Other information

Store at room temperature 15° - 30°C (59°F – 86°F).

Inactive ingredients

Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Methylparaben, Polysorbate 60, Propylparaben, Sodium Hydroxide, Sodium Lauryl Sulfate, Water

Questions or comments?

1-800-645-2158

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

NDC 0536-1101-45

Rugby®
MAXIMUM STRENGTH

PAIN RELIEVING
CREAM

Net Wt 3 oz (85 g)

RUGBY PAIN RELIEVING   ANALGESIC
menthol, unspecified form and methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
Methyl Salicylate (SALICYLIC ACID) Methyl Salicylate150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
Cetostearyl Alcohol 
Dimethicone 
Glycerin 
Methylparaben 
Polysorbate 60 
Propylparaben 
Sodium Hydroxide 
Sodium Lauryl Sulfate 
Water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1101-451 TUBE in 1 CARTON
185 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/11/2016
Labeler - Rugby Laboratories (079246066)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIOperations
Garcoa, Inc.103039178MANUFACTURE(0536-1101)

 
Rugby Laboratories

Medically reviewed on Oct 18, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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