Label: CVS CAPSAICIN- capsaicin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 8, 2010

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient                                 Purpose

    Capsaicin 0.1%............................................Topical analgesic
  • PURPOSE



    Uses     for the temporary relieves of minor aches and pains of muscles and joints associated with:
    - arthritis - simple backache - strains - bruises
  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children. If case of overdose or allergic reaction, seek medical attention or contact
    a Poison Control Center right away.
  • INDICATIONS & USAGE


    Uses for the temporary relieves of minor aches and pains of muscles and joints associated with:
    - arthritis - simple backache - strains - bruises
  • WARNINGS

    Warnings

    For external use only

    When using this product

    - use only as directed - do not apply to wounds, damaged, broken or irritated skin - avoid contact
    with the eyes or mucous membranes - 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 bandage - do not use with heating pad

    Stop use and consult a dentist or 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 the reach of children.In case of overdose or allergic reaction,
    seek medical attention or contact a Poison Control Center right away.

    If pregnant or breast feeding, ask a health professional before use.
  • DOSAGE & ADMINISTRATION


    Directions 

    Adults and children over 18 years
    - apply to affected area
    - Massage into the painful area until thoroughly absorbed
    - Repeat as necessary, but no more than 3 to 4 times daily
    - WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    Children 18 years and younger: ask a doctor.



  • INACTIVE INGREDIENT

    Inactive Ingredients

    purified water, petrolatum, cetyl alcohol glyceryl stearate, PEG-40 stearate, isopropyl myristate, sorbitol, PEG-2 stearate, benzyl alcohol
  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-622
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIGLYCOL STEARATE (UNII: 94YQ11Y95F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITOL (UNII: 506T60A25R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-622-651 in 1 CARTON
    142.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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!