Label: MEIJER 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 October 11, 2016

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                       Purpose

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

  • PURPOSE

    Uses

    For the temporary relief of minor pain associated with:

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

    Warnings

    For external use only

  • WHEN USING

    When using this product

    • use only as directed
    • do not bandage
    • do not use with 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

    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
    • irritation develops
  • 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:

    • apply generously to affected area not more than 3 to 4 times daily
    • massage into painful area until thoroughly absorbed
    • wash hands with soap and water after use
    • close cap tightly after use

    Children 18 years or younger: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzyl alcohol, cetyl alcohol, isopropyl myristate, polyoxyl 40 stearate, purified water, sorbitan, monostearate, sorbitol solution, white petrolatum

  • DOSAGE & ADMINISTRATION

    DIST. BY MEIJER DISTRIBUTION, INC.

    2929 WALKER AVE NW

    GRAND RAPIDS, MI 49544

    www.meijer.com

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    MEIJER CAPSAICIN 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-256
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.1 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    SORBITOL (UNII: 506T60A25R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-256-421 in 1 CARTON10/11/2016
    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 finalpart34811/30/2012
    Labeler - MEIJER, INC. (006959555)