Label: RITE AID CAPSICUM HOT- capsaicin patch

  • 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 December 10, 2019

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

  • ACTIVE INGREDIENT

    Active ingredient                                                                                                     Purpose

    Capsicum extract 0.025% as Capsaicin....................................................................Topical analgesic

  • PURPOSE

    Uses

    Temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • strains
    • sprains
    • bruises
  • WARNINGS

    Warnings

    • For external use only
    • Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product
  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
  • WHEN USING

    When using this product

    • avoid contact with eyes and mucous membranes or rashes
    • do not bandage tightly
    • discontinue use at least 1 hour before a bath or shower
    • do not use immediately after a bath or shower
  • STOP USE

    Stop use and ask a doctor if

    • conditions worsens, symptoms persist more than 7 days or clear up and occur again within a few days
    • redness is present or irritation or rash 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 right away.

  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older:

    clean and dry affected area

    remove patch from film

    apply to affected area no more than 3 to 4 times daily

    do not wear patch for more than 8 hours

    children under 12 years of age: consult a doctor

  • STORAGE AND HANDLING

    Other information

    • avoid storing product in direct sunlight
    • protect product from excessive moisture
  • INACTIVE INGREDIENT

    Inactive ingredients

    butylhydroxytoluene, glyceryl rosinate, isopropyl myristate, natural rubber, polybutene, polyisobutylene, carbonate, propylene carbonate, sorbitan stearate, terpene resin (quinton), terpene resin (ys resin), titanium dioxide, zinc oxide

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE

    CAMP HILL, PA 17011

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    57448.1

  • INGREDIENTS AND APPEARANCE
    RITE AID CAPSICUM HOT 
    capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5744
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5744-33 in 1 POUCH; Type 0: Not a Combination Product11/30/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/30/2012
    Labeler - RITE AID CORPORATION (014578892)