FDA.reportPublic FDA data

CANNAVERA PAIN RELIEF

Manufacturer
Leading Edge Pharms, Inc.
Effective date
2023-08-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:55:54

Label at a glance#

ProductCANNAVERA PAIN RELIEF
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

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

Dosage and administration

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 years ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin, 0.10%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

IF PREGNANT OR BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

• 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.

OTC - DO NOT USE SECTION

• If you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

• Store at 15° - 30°C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-888-536-2872

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80295-100-012025-01-30C16284748780-12cef2736-9e83-d83d-e063-dadaa90ab31fCANNAVERA PAIN RELIEF OIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80295-100-01CANNAVERA PAIN RELIEF1 in 1 BOXOIL11
80295-100-01CANNAVERA PAIN RELIEF30 mL in 1 BOTTLEOIL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80295-100CANNAVERA PAIN RELIEF (CAPSAICIN) OIL [LEADING EDGE PHARMS, INC.]12 package rows20230818_8c54f691-e4c9-4b3a-820e-d83e24aa184c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80295-10080295-100-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRICAPRINO1PB8EU98MIACT
GRAPE SEED OIL930MLC8XGGIACT
EUCALYPTUS OIL2R04ONI662IACT
PROPANEDIOL5965N8W85TIACT
CANNABIS SATIVA WHOLEB5ONF538PBIACT
ALOE VERA LEAFZY81Z83H0XIACT
SAGE065C5D077JIACT
ROSEMARYIJ67X351P9IACT
ALMOND OIL66YXD4DKO9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
LAVENDER OILZBP1YXW0H8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CAPSAICINS07O44R1ZMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
031b1035-b933-ea0e-e063-6394a90a4d908c54f691-e4c9-4b3a-820e-d83e24aa184c2023-08-17WarningsExact identifier
spl id: 031b1035-b933-ea0e-e063-6394a90a4d90
spl set id: 8c54f691-e4c9-4b3a-820e-d83e24aa184c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.