Label: CVS CAPSAICIN ARTHRITIS PAIN RELIEF- capsaicin liquid

  • 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 May 8, 2019

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

  • Active Ingredient

    Capsaicin 0.15%........................................................................................................................... Topical analgesic

  • Purpose

    Arthritis Pain Relief

  • Uses

    temporarily relieves minor aches and pains of muscles and joints due to:

    simple backache

    arthritis

    strains

    bruises

    sprains

  • warnings

    For external use only

    Do Not Use

    on wounds, damaged, broken or irritated skin

    When using this product

    use only as directed

    do not bandage tightly or cover treated area

    do not use with a heating pad

    do not get into eyes or on mucous membranes

    a transient burning sensation may occur upon application but generally disappears in several days

    if severe burning sensation occurs, discontinue use immediately and read inside of carton for important information

    do not expose the area treated with product to heat or direct sunlight

    Stop use and ask a doctor if

    condition gets worse

    redness is present

    irritation develops

    symptoms last for more than 7 days or clear up and occur again within a few days

    If pregnant or beast-feeding

    ask a health professional before use.

    Keep out of reach of children

    . If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply to affected area

    place applicator on skin, press firmly and hold to activate the dispensing of liquid

    massage into painful area until thoroughly absorbed

    repeat as necessary, but no more than 3 to 4 times daily

    if medicine comes in contact with hands, wash with soap and water

  • storage

    Store between 20 °C and 25 °C (68 °F and 77 °F). Close cap tightly after use.

  • PLEASE READ AND KEEP THESE DIRECTIOINS

    What is capsaicin? Capsaicin, a naturally occuring substance derived from hot peppers, is a safe and effective topical analgesic for arthritis pain.

    What does capsaicin do? When applied to the affected area, capsaicin penetrates deep and specically targets pain transmitting neurons by progressively deteriorating their ability to signal pain to the brain, effectively relieving minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises.

    When used every day, as directed, the effectiveness of capsaicin continues to build more and more. The amount of time required for pain relief to occur varies with each person. Some arthritis sufferers may obtain relief within the rst week of use, while others may experience relief later. This product can be used for all types of arthritis.

    Are there any side effects? Due to the nature of capsaicin, a mild tolerable burning and/or itching sensation may be experienced when the product is applied which may last up to 48 hours. This mild burning and/or itching sensation typically diminishes with continued use, and is not a reason to discontinue using this product.

    Severe discomfort has been reported in some individuals. If severe burning and/or itching occurs, discontinue use immediately and remove excess product by thoroughly washing with soap and cold water. If regular soap and water does not completely wash away the residue, try using dishwashing liquid or cooking oil at room temperature. This discomfort can be expected to subside completely. If you experience blistering, or signicant improvement does not occur, stop use and contact your doctor.

    Warm or hot water, direct sunlight or exposure to heat may increase the likelihood of burning and itching. Therefore, do not apply immediately before or after activities such as bathing, swimming, using a hot tub, sunbathing or exposure to heat.

    • If you are a rst time user and think your skin might be sensitive to capsaicin, test it on a small area rst.

    • Children 18 years of age or younger: consult a doctor before using.

    • Wear gloves to apply or, if medicine comes in contact with hands, wash with soap and water after applying to avoid spreading to the eyes or other sensitive areas of the body. Try using dishwashing liquid or cooking oil at room temperature if regular soap and water does not completely wash the product from your hands. If product gets into the eyes, ush with water.

    • Apply to affected area and using the applicator, press rmly on skin and hold to activate the dispensing of liquid. Massage into painful area until thoroughly absorbed.

    • If you are using capsaicin on your hands, allow 30 minutes for it to penetrate before washing. During this time avoid touching damaged or irritated skin and avoid contact with the eyes and mucous membranes. After 30 minutes, wash hands with soap and water.

    • If you wear contact lenses, avoid touching them after applying this product. Handle lenses before use.

    CVS capsaicin facts .jpg

  • Inactive ingredients

    carbomer 940, glycerin, propylene glycol, purified water, SD alcohol 40-B (40%), trolamine

  • principal display panel

    CVS Health

    Deep Penetrating

    Capsaicin0.15%

    ARTHRITIS PAIN RELIEF

    • Topical analgesic liquid

    • High potency

    • Odor free

    Compare to the active ingredient in Capzasin™*

    No Touch Applicator

    cvs capsaicin .jpg

  • INGREDIENTS AND APPEARANCE
    CVS CAPSAICIN ARTHRITIS PAIN RELIEF 
    capsaicin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-313-011 in 1 BOX03/26/2019
    128.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/26/2019
    Labeler - CVS (062312574)
    Registrant - Weeks & Leo, Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    weeks & Leo005290028manufacture(69842-313)