Label: CAPSAICIN- arthritis pain relief 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 5, 2020

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

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

  • PURPOSE

    Uses

    • temporarily relieves minor pain of muscles and joints associated with:
    • arthritis
    • simple backache
    • 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 the eyes or mucous membranes
    • do not bandage tightly
    • a transient burning sensation may occur upon application 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 irriration 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • adults and children 18 years of age and older:
    • 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
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactivate ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Rite Aid

    30 Hunter Lane

    Camp Hill, PA 17011

    Made in China

  • PRINCIPAL DISPLAY PANEL

    78846

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN 
    arthritis pain relief cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7884
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7884-11 in 1 CARTON02/21/2020
    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 finalpart34802/21/2020
    Labeler - Rite Aid (014578892)
    Registrant - United Exchange Corp. (840130579)