CANNAVERA PAIN RELIEF- capsaicin oil 
Leading Edge Pharms, Inc.

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.

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CANNAVERA PAIN RELIEF OIL

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

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)

Revised: 8/2023
Document Id: 031b1035-b933-ea0e-e063-6394a90a4d90
Set id: 8c54f691-e4c9-4b3a-820e-d83e24aa184c
Version: 1
Effective Time: 20230817
 
Leading Edge Pharms, Inc.