CAPSAICIN   - capsaicin cream 
Physicians Total Care, 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

Stop use and ask doctor if

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:

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)




Capsaicin Cream, 0.025%

External Analgesic

Penetrating Pain Relief

Net Wt 2.1 oz (60 g)

image of package  label


CAPSAICIN  
capsaicin external analgesic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3760(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
ACETYLATED LANOLIN ALCOHOLS 
cetyl acetate 
methylparaben 
propylene glycol 
propylparaben 
stearic acid 
stearyl alcohol 
TROLAMINE 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:54868-3760-01 TUBE ( TUBE) in 1 CARTONcontains a TUBE
160 g in 1 TUBEThis package is contained within the CARTON (54868-3760-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/13/200901/15/2013

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

Revised: 01/2013 Physicians Total Care, Inc.