RUGBY CAPSAICIN  EXTERNAL ANALGESIC- capsaicin cream 
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® 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®

SATISFACTION GUARANTEED
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 Type HUMAN OTC DRUG Item Code (Source) NDC:0536-2525
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 0.025 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-2525-25 1 in 1 CARTON
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 03/01/2012
Labeler - Rugby Laboratories, Inc. (191427277)
Registrant - Garcoa, Inc. (103039178)
Establishment
Name Address ID/FEI Business Operations
Garcoa, Inc. 103039178 MANUFACTURE(0536-2525)

Revised: 2/2013
Document Id: 9baba6ad-a694-4cf3-b86e-65bffa7d460b
Set id: c5915c84-84a2-46f6-9f97-0d9873e9944a
Version: 2
Effective Time: 20130201
 
Rugby Laboratories, Inc.