Label: CANNAVERA PAIN RELIEF- capsaicin oil

  • NDC Code(s): 80295-100-01
  • Packager: Leading Edge Pharms, Inc.
  • 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 17, 2023

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

View All Sections
  • DRUG FACTS

  • Active Ingredients

    Capsaicin, 0.10%

    Purpose

    External Analgesic

  • Uses

    For temporary relief of minor aches and pains of muscles and joints due to:
    • simple backache • arthritis • strains • bruises • sprains

  • Warnings

    For external use only.
    Read all warnings and directions before use.
    Test first on small area of skin.

    IF PREGNANT OR BREASTFEEDING

    • Ask a health professional before use.
    • CA AB-45: the FDA strongly advises against the use of cannabis, including CBD, in any form, during pregnancy or while breastfeeding.

    Do not use.

    • If you are allergic to any ingredients of this product

    When using this product

    • You may experience a burning sensation that generally disappears after several days of regular use. The intensity of this reaction varies among individuals and may be severe. 
    • Avoid contact with the eyes or mucous membranes. • Do not bandage tightly or use with a heating pad.

    Stop use and ask a doctor if

    • Condition worsens or does not improve after regular use. • Severe burning persists or blistering occurs.

    Keep out of reach of children.

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

  • Directions:

    Adults and children 18 years of age or older
    • Apply a thin film of oil to affected area and gently rub in until fully absorbed • Wash hands with soap and water after use • Apply to affected area not more than 3 to 4 times daily.
    Children under 18 yearsask a doctor

  • Other information

    • Store at 15° - 30°C (59° - 86°F)

  • Inactive Ingredients

    Capric Triglycerides, Grape Seed Oil, Rosehip Oil, Passion Fruit Seed Oil, Eucalyptus Leaf Oil, Propanediol, Ethanol SDA 3A, Hemp (Cannabis sativa L.) Leaf Extract, hosphatidylcholine, Aloe Barbadensis Leaf Powder, Sage Leaf Extract, Arnica Leaf Extract, Rosemary Leaf Extract, Bergamot Fruit Oil, Sweet Almond Oil, Tocopherol Acetate, C12-15 Alkyl Benzoate, Lavender Oil, Chamomile Flower Extract, Capryl Glycol, Hexylene Glycol, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate, Ascorbic Acid Tocopherol Acetate, Citric Acid.

  • Questions?

    Call 1-888-536-2872

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CANNAVERA PAIN RELIEF 
    capsaicin oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80295-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRICAPRIN (UNII: O1PB8EU98M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CANNABIS SATIVA WHOLE (UNII: B5ONF538PB)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAGE (UNII: 065C5D077J)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80295-100-011 in 1 BOX08/01/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2023
    Labeler - Leading Edge Pharms, Inc. (071092942)
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!