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
  • 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 August 4, 2023

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

    CAPSAICIN 0.1% / TOPICAL ANALGESIC CREAM
    High Potency

    CAPSAICIN HP

    ARTHRITIS PAIN RELIEF

    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 Stearate (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 not finalpart34808/21/2023
    Labeler - Nationwide Pharmaceutical LLC (079265801)