FDA.reportPublic FDA data

Capsiva

Manufacturer
ANESIS LIFE, LLC | BIOLYTE LABORATORIES, LLC
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:22:55

Label at a glance#

ProductCapsiva
Active ingredientCAPSICUM, ARNICA MONTANA
Label structure8 sections

Indications and uses

Temporarily relieves minor pain associated with: arthritis muscle back joint Claims based on traditional homeopathic practices, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults and children 12 years of age and older apply gel on clean skin enough to cover affected area apply to area of pain, as needed adjust usage to achieve desired pain reduction do not use over other topical remedies after applying, wash hands with soap and water

Storage and handling

Store in a cool, dry place. Avoid direct sunlight and heat. Do not use if the seal is broken or missing.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsicum Annuum 1X

Arnica Montana 1X

Purpose

OTC - PURPOSE SECTION

Capsicum Annuum 1X......................Topical Analgesic

Arnica Montana 1X...........................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

  • arthritis
  • muscle
  • back
  • joint

Claims based on traditional homeopathic practices, not accepted medical evidence. Not FDA evaluated.

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • use only as directed
  • avoid contact with eyes and open wounds
  • in case of accidental contact with eyes, immediately flush with water and seek professional help
  • do not apply local heat (such as heating pads) to the area of use
  • do not cover or bandage

OTC - STOP USE SECTION

Stop use and ask physician ifcondition worsens or persists, or a rash occurs

OTC - ASK DOCTOR SECTION

Ask a physician before use ifyou are taking prescription medications or have a serious medical condition

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding,ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older

  • apply gel on clean skin enough to cover affected area
  • apply to area of pain, as needed
  • adjust usage to achieve desired pain reduction
  • do not use over other topical remedies
  • after applying, wash hands with soap and water

Other information

STORAGE AND HANDLING SECTION

Store in a cool, dry place. Avoid direct sunlight and heat. Do not use if the seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf, Benzyl Alcohol, Cucumis Sativus (Cucumber) Extract, Ethyl Alcohol, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isopropyl Alcohol, Salicylic Acid, Sorbic Acid, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 72522-104-03

Arthritis Pain Relief Roll-On

Capsiva

Homeopathic

Natural Active Ingredients

Odor Free

Safe & Effective

Absorbs Fast

*100% Money Back Guarantee

Real, Risk-Free* Relief

Net Wt 3 oz (88.7 mL)

11

22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72522-104-03Capsiva88.7 mL in 1 CONTAINERGEL88.72
72522-104-03Capsiva1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72522-104CAPSIVA (CAPSICUM ANNUUM, ARNICA MONTANA) GEL [ANESIS LIFE, LLC]2Current NDC, Legacy NDC, 2 package rows20231030_de5f8ab8-941b-0fbe-e053-2a95a90a78bb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72522-10472522-104-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
SALICYLIC ACIDO414PZ4LPZIACT
CUCUMBERYY7C30VXJTIACT
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
SORBIC ACIDX045WJ989BIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPSICUM00UK7646FGACTIB
ARNICA MONTANAO80TY208ZWACTIB

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
CapsivaCAPSICUM ANNUUM, ARNICA MONTANAANESIS LIFE, LLCde5f8ab8-941b-0fbe-e053-2a95a90a78bb2023-10-27WarningsExact identifier
ndc (package): 72522-104-03
ndc (product): 72522-104
ndc11 (package): 72522010403
spl id: 08b4af19-3927-477f-e063-6294a90a5a4a
spl set id: de5f8ab8-941b-0fbe-e053-2a95a90a78bb

Reported adverse events (FAERS/openFDA)#

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