Label: CAPSAICIN CREAM- capsaicin 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 November 9, 2022

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

View All Sections
  • Drug Facts

  • Active Ingredient

    Capsaicin 0.1%

  • Purpose

    Topical Analgesic

  • Warnings

    For external use only: TEST FIRST ON SMALL AREA OF SKIN.

    When using this product:

    • Use only as directed
    • Do not apply to wounds, damaged, broken or irritated skin
    • Do not use if you are allergic to capsicum or chili peppers
    • Avoid contact with the eyes or mucous membranes
    • A slight burning sensation may occur upon application, but generally disappears after several days
    • If severe burning occurs, discontinue use
    • Do not expose the treated area to heat or direct sunlight
    • Do not bandage
    • Do not use with heating pad
    • Do not use at the same time as other topical analgesics
  • Stop Use and Ask Doctor

    Stop Use and Ask Doctor if:

    • Condition worsens
    • Symptoms persist for more than 7 days or clear up and occur again within a few days
    • Redness is present
    • irritation develops
    • You experience signs of skin injury such as pain, swelling or blistering.
  • Keep Out of the Reach of Children

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

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Arthritis
    • Simple Backache
    • Strains
    • Sprains
    • Bruises
  • If Pregnant or Breast Feeding

    Ask a doctor before use

  • Directions

    Adults and Children over 18 years:

    • Apply to affected area
    • Massage into the painful area until thoroughly absorbed
    • Repeat as necessary but not more than 3 to 4 times daily
    • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    Children 18 years and younger:

    Ask a doctor

  • Inactive Ingredients

    Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid

  • Other Information

    Store at room temperature 15°-30°F (59°-86°F)

    This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.

  • Questions

    Questions or Comments

    Please call Toll Free 1-888-296-9067

  • Other Information

    Manufactured for

    Noble OTC LLC

    Perth Amboy, NJ 08861

    www.nobleotc.com

    This product is not manufactured or distributed by Chattem, a distributor of Capzaicin-HP Arthritis Pain Relief

  • PRINCIPAL DISPLAY PANEL

    Noble Capsaicin Cream 1.5oz CDER

  • INGREDIENTS AND APPEARANCE
    CAPSAICIN CREAM 
    capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81533-200
    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
    LAURETH-23 (UNII: N72LMW566G)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81533-200-151 in 1 BOX07/14/2022
    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 finalpart34807/14/2022
    Labeler - Noble OTC LLC (041836435)
    Registrant - Trifecta Pharmaceuticals USA LLC (079424163)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!