Your browser does not support JavaScript! RUGBY CAPSAICIN EXTERNAL ANALGESIC (CAPSAICIN) CREAM [RUGBY LABORATORIES, INC.]
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RUGBY CAPSAICIN EXTERNAL ANALGESIC (capsaicin) cream
[Rugby Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient

Capsaicin 0.025%

Purpose

External 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 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:

  • 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° - 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
OR YOUR MONEY BACK

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 DRUG LABELItem Code (Source)NDC:0536-2525
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Cetyl Acetate 
Methylparaben 
PPG-20 Methyl Glucose Ether Distearate 
Propylene Glycol 
Propylparaben 
Steareth-100 
Stearic Acid 
Stearyl Alcohol 
Trolamine 
Water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-2525-251 in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34803/01/2012
Labeler - Rugby Laboratories, Inc. (191427277)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.103039178MANUFACTURE(0536-2525)

Revised: 2/2013
 
Rugby Laboratories, Inc.

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