Label: WALGREENS ARTHRITIS PAIN RELIEF CAPSAICIN ANALGESIC- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 16, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsaicin 0.1%

  • Purpose

    Topical Analgesic

  • Uses

    for the temporarily relief of minor aches and pains of muscles and joints associated with

    ♦
    arthritis
    ♦
    simple backache
    ♦
    strains
    ♦
    sprains
    ♦
    bruises
  • Warnings

    For external use only: Be sure to read product brochure before using. TEST FIRST ON SMALL AREA OF SKIN.

    When using this product

    ♦
    use only as directed
    ♦
    do not bandage tightly
    ♦
    do not use with a heating pad
    ♦
    avoid contact with eyes and mucous membranes
    ♦
    do not apply to wounds, damaged, broken or irritated skin
    ♦
    a slight burning sensation may occur upon application but generally disappears in several days
    ♦
    if severe burning occurs, discontinue use
    ♦
    do not expose the treated area to heat or direct sunlight
    ♦
    do not use if allergic to capsicum or chili peppers

    Stop use and consult a doctor if

    ♦
    condition worsens
    ♦
    symptoms persist for more than 7 days or clear up and occur again within a few days
    ♦
    redness is present
    ♦
    irritation develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

    If pregnant or breast- feeding, ask a health care professional before use

  • Directions

    ♦
    adults and children 18 years of age and older: apply to affected area not more than 3 to 4 times daily
    ♦
    massage into area until thoroughly absorbed
    ♦
    WASH HANDS WITH SOAP AND WATER AFTER APPLYING
    ♦
    children under 18 years of age: consult a doctor
  • Other information

    store at room temperature

  • Inactive ingredients

    acrylates/C10-30 slkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, sodium hydroxide, steareth-100, stearic acid, stearyl alcohol, water

  • Questions or comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

    ARTHRITIS PAIN RELIEF
    Capsaicin

    CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

    NET WT 1.5 OZ (42.5 g)

    PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS ARTHRITIS PAIN RELIEF CAPSAICIN ANALGESIC 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0837
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Cetyl Acetate (UNII: 4Q43814HXS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PPG-20 Methyl Glucose Ether Distearate (UNII: 0057334FAB)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Steareth-100 (UNII: 4OH5W9UM87)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0837-011 in 1 CARTON05/03/2010
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/03/2010
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(0363-0837)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!