CAPSAICIN EXTERNAL ANALGESIC - capsaicin cream 
Rugby Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient             Capsaicin 0.025%


For external use only
Do not use on wounds or damaged skin

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

If swallowed, get medical help or contact a Poison Control Center immediately.

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

Questions or comments? Call 1-800-645-2158 9 am - 5 pm EST, Monday - Friday

Directions
Adults and children 12 years 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 optimum results, apply 3 to 4 times daily
Children under 12 years: ask a doctor
Uses temporary relieves minor aches and pains of muscles and joints due to - simple backache - arthritis - strains - sprains
Other information store at room temperature 15C-30C (59F-86F)


pictires
U Carton
Bottle
CAPSAICIN EXTERNAL ANALGESIC 
capsaicin external analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem 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
Packaging
#Item CodePackage Description
1NDC:0536-2525-2524 in 1 CASE
11 in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/1998
Labeler - Rugby Laboratories, Inc. (109178264)
Registrant - Harmony Labs, Inc. (105803274)
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack

Revised: 04/2010
 
Rugby Laboratories, Inc.