Label: CAPSAICIN HP ARTHRITIS PAIN RELIEF- capsaicin cream

  • NDC Code(s): 69375-006-60
  • Packager: Nationwide Pharmaceutical LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Capsaicin 0.1%

  • Purpose

    Topical analgesic

  • Uses

    temporarily relieves minor pain associated with:

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
  • Warnings

    For external use only

    When using this product

    • If you are a first time user and think your skin might be sensitive to Capsaicin, test it on a small area first
    • rare cases of serious burns have been reported with products of this type
    • do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skln
    • a transient burning sensation may occur upon application but generally disappears in several days
    • if severe burning occurs, discontinue use immediately and read inside carton for important Information
    • do not expose the area treated with product to heat or direct sunlight do not use al the same time as other topical analgesics
    • use only as directed. Read and follow all directions and warnings on this carton
    • do not use if you are allergic to capsaicin or chili peppers

    Stop use and ask a doctor if

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

  • Directions

    adults and children over 18 years:

    • apply to affected area
    • massage into painful area until thoroughly absorbed
    • repeat if necessary, but no more than 3 to 4 times daily
    • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    children 18 years or younger: ask a doctor

  • STORAGE AND HANDLING

    • store at 15°-25°C (59°-77°F)
  • Inactive ingredients

    benzyl alcohol, isopropyl myristate, cetyl alcohol, PEG-40 stearate, glyceryl stearate, sorbitol, petroleum jelly, water

  • Questions: or comments

    1-800-697-3329

  • SPL UNCLASSIFIED SECTION

    Manufactured for and Distributed by:
    Nationwide Pharmaceutical
    San Antonio, TX, 78216

  • PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton

    Nationwide
    Pharmaceutical

    • Deep Penetrating • Odor Free

    NDC# 69375-0006-60

    CAPSAICIN HP
    High Potency

    CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM

    ARTHRITIS PAIN RELIEF

    Compare to the
    active ingredient
    in Capzasin HP®††

    NET WT 2.0 oz (56.6 g)

    PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CAPSAICIN HP ARTHRITIS PAIN RELIEF 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69375-006
    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
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Sorbitol (UNII: 506T60A25R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69375-006-601 in 1 CARTON08/21/2023
    156.6 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01708/21/2023
    Labeler - Nationwide Pharmaceutical LLC (079265801)