Label: CVS CAPSAICIN- 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 March 31, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                      Purpose

    Capsaicin 0.1%........................................................................Topical analgesic

  • PURPOSE

    For the temporary relief of minor pain associated with:

    • Arthritis
    • Simple backache
    • Muscle strains
    • Sprains
    • Bruises
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • on wounds, damaged, broken or irritated skin
    • with a heating pad
    • if you are allergic to capsicum or chili peppers
  • WHEN USING

    When using this product

    • avoid contact with eyes and mucous membranes
    • do not bandage tightly
    • a transient burning sensation may occur upon applications but generally disappears in several days
    • do not expose the treated area to heat or direct sunlight
  • STOP USE

    Stop use and ask 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 or irritation develops
    • a severe burning sensation occurs
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children over 18 years:

    • use only as directed
    • apply to affected area
    • massage into 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 under 18 years of age: ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, cetyl alcohol, isopropyl myristate, petrolatum, polyoxyl 40 stearate, water, sorbitan monostearate, sorbitol

  • DOSAGE & ADMINISTRATION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    www.cvs.com

    Made in China

  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No. and Exp. Date: see box or crimp of tube
    • save carton for complete Drug Facts information
  • PRINCIPAL DISPLAY PANEL

    33754.1

  • INGREDIENTS AND APPEARANCE
    CVS CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    SORBITOL (UNII: 506T60A25R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-381-421 in 1 CARTON10/13/2014
    142 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 finalpart34810/13/2014
    Labeler - CVS PHARMACY (062312574)