Your browser does not support JavaScript! WALGREENS CAPSAICIN HOT (CAPSAICIN EXTRACT) PATCH [WALGREEN CO]
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WALGREENS CAPSAICIN HOT (capsaicin extract) patch
[Walgreen Co]


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

Active ingredient                                                                                   Purpose

Capsaicin extract 0.025% as Capsaicin.....................................Topical Analgesic

Uses Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

  • For external use only
  • Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower
  • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.

If pregnant or breastfeeding consult a healthcare professional before use.

Do not use

  • on wounds or damaged skin
  • with, or at the same time as, other external analgesic products

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes or rashes

Stop use and ask a doctor if

  • conditions worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching or excessive skin irritation develops

Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 12 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily for 7 days
  • remove patch from the skin after at most 8 hours application
  • Children under 12 years of age: consult a doctor

Other information

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive ingredients BHT, Ester gum, isopropyl myristate, natural rubber, polybutene, polysobutylene, precipitated calcium carbonate, propylene carbonate, quinton, sorbitan monostearate, titanium dioxide, YS resin, Zinc oxide

Distributed By:

Walgreen Co

200 Wilmot Rd.

Deerfield, IL 60005

Made in Korea

image of carton label

WALGREENS CAPSAICIN HOT 
capsaicin extract patch
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0363-9113
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.6 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
ISOPROPYL MYRISTATE 
NATURAL LATEX RUBBER 
POLYBUTENE (1400 MW) 
PROPYLENE CARBONATE 
SORBITAN MONOSTEARATE 
TITANIUM DIOXIDE 
ZINC OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9113-033 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2013
Labeler - Walgreen Co (008965063)

Revised: 6/2013
 
Walgreen Co

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