RUGBY ARTHRITIS PAIN RELIEVING  TOPICAL ANALGESIC- capsaicin cream 
Rugby Laboratories

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 ® Arthritis Pain Relieving Cream

Drug Facts

Active ingredient

Capsaicin 0.075%

Purpose

Topical Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

simple backache
arthritis
strains
sprains

Warnings

For external use only

Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

Do not use

on wounds or damaged skin
if you are allergic to capsicum or chili peppers

When using this product

you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
avoid contact with eyes, lips, nose and mucous membranes
do not tightly wrap or bandage the treated area
do not apply heat to the treated area immediately before or after use

Stop and ask a doctor if

condition worsens or does not improve after regular use
severe burning persists or blistering occurs

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

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

Directions

Adults and children 18 years of age and older:

apply a thin film of cream to affected area and gently rub in until fully absorbed
unless treating hands, wash hands thoroughly with soap and water immediately after application
for best results, apply 3 to 4 times daily.

Children under 18 years: ask a doctor

Other information

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

Inactive ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, petrolatum, sorbitol, water

Questions or comments?

1-800-645-2158

Distributed by: Rugby Laboratories
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton

NDC 0536-1118-25

Rugby ®

COMPARE TO
ZOSTRIX® HP
ACTIVE INGREDIENT*

HIGH POTENCY
ARTHRITIS PAIN RELIEVING CREAM
0.075% CAPSAICIN TOPICAL ANALGESIC

Odor Free Formula • Clinically Tested Active Ingredient
Net Wt 2 oz (57 g)

PRINCIPAL DISPLAY PANEL - 57 g Tube Carton
RUGBY ARTHRITIS PAIN RELIEVING   TOPICAL ANALGESIC
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Benzyl Alcohol (UNII: LKG8494WBH)  
Cetyl Alcohol (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
PEG-100 Stearate (UNII: YD01N1999R)  
Petrolatum (UNII: 4T6H12BN9U)  
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1118-251 in 1 CARTON05/24/2017
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/24/2017
Labeler - Rugby Laboratories (079246066)
Registrant - Garcoa, Inc (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc036464697MANUFACTURE(0536-1118)

Revised: 5/2017
Document Id: c2e43f36-46f6-4947-8ef1-00919f706979
Set id: 8f1bc075-97ac-4154-8768-0d878104c3ba
Version: 1
Effective Time: 20170526
 
Rugby Laboratories