FDA.reportPublic FDA data

Capsiva

Manufacturer
BioLyte Laboratories, LLC
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:41:16

Label at a glance#

ProductCapsiva
Active ingredientCAPSICUM, ARNICA MONTANA
Label structure13 sections

Indications and uses

Temporarily relieves minor pains associated with: Arthritis Muscle Back Joint Headache

Dosage and administration

Directions 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

Other Information Store in a cool, dry place. Avoid direct sunlight and heat.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Capsicum Annuum 6X.......................... Topical Analgesic

Arnica Montana 6X............................... Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Active Ingredients Purpose

Capsicum Annuum 6X.......................... Topical Analgesic

Arnica Montana 6X............................... Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pains associated with:

Arthritis

Muscle

Back

Joint

Headache

Warnings

WARNINGS SECTION

Warnings

For external use only

● 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

Stop use and ask a physician if:

OTC - ASK DOCTOR SECTION

Stop use and ask a physician if: Condition worsens or persists, or a rash occurs

Ask a physician before use if:

OTC - ASK DOCTOR SECTION

Ask a physician before use if: ● You are taking prescription medications or have a serious medical condition ● You are pregnant or breast-feeding

Not intended for children under 3 years of age

WARNINGS SECTION

Not intended for children under 3 years of age

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

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

Other Information

Store in a cool, dry place. Avoid direct sunlight and heat.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

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

Questions or Comments

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-888-212-8188

www.capsiva.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Capsiva Pain Relieving Gel Roll-OnCapsiva Pain Relieving Gel Roll-On

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58368-10258368-102-84

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ACRYLOYLDIMETHYLTAURATE2T9Q6EKI0GIACT
ALOE VERA LEAFZY81Z83H0XIACT
CUCUMBERYY7C30VXJTIACT
ISOPROPYL ALCOHOLND2M416302IACT
BENZYL ALCOHOLLKG8494WBHIACT
CAPSICUM00UK7646FGACTIB
GLYCERINPDC6A3C0OXIACT
ARNICA MONTANAO80TY208ZWACTIB
SORBIC ACIDX045WJ989BIACT
SALICYLIC ACIDO414PZ4LPZIACT
2-HYDROXYETHYL ACRYLATE25GT92NY0CIACT

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
0f0104a7-d7ed-047b-e063-6394a90ad61bd0ef337c-bdbb-6de9-e053-2a95a90ae7292024-01-15WarningsExact identifier
spl set id: d0ef337c-bdbb-6de9-e053-2a95a90ae729

Reported adverse events (FAERS/openFDA)#

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