RUGBY CAPSAICIN  EXTERNAL ANALGESIC- capsaicin cream 
Rugby Laboratories

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Rugby® Capsaicin Cream
External Analgesic

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External analgesic

Uses

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

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 the 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 use 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.

Directions

Adults and children 18 years of age and older:

Children under 18 years: ask a doctor

Other information

store at room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Mfd for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

NDC 0536-2525-25

Rugby®

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Capsaicin Cream, 0.025%

External Analgesic
Penetrating Pain Relief

Net Wt 2.1 oz (60 g)

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
RUGBY CAPSAICIN   EXTERNAL ANALGESIC
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-2525
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
Cetyl Acetate (UNII: 4Q43814HXS)  
Methylparaben (UNII: A2I8C7HI9T)  
PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Steareth-100 (UNII: 4OH5W9UM87)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Trolamine (UNII: 9O3K93S3TK)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-2525-251 in 1 CARTON03/01/2012
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM01703/01/2012
Labeler - Rugby Laboratories (079246066)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries, Inc.255106239MANUFACTURE(0536-2525)

Revised: 2/2024
Document Id: d8016267-c07e-4c75-8595-dce6d4cbd123
Set id: c5915c84-84a2-46f6-9f97-0d9873e9944a
Version: 6
Effective Time: 20240212
 
Rugby Laboratories