FDA.reportPublic FDA data

BIOSAVIA External Analgesic Pain Relief Gel

Manufacturer
BIOSAVIA USA, LLC
Effective date
2024-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:02

Label at a glance#

ProductBIOSAVIA External Analgesic Pain Relief
Active ingredientCAPSAICIN
Label structure8 sections

Indications and uses

Temporaryly relieves minor aches and pains of muscles and joints associated with strains bruises sprains arthritis simple neck or back ache

Dosage and administration

Adults and children 2 years of age and older apply liberally onto affected area not more than 3 to 4 times daily Massage evenly where needed until the gel is fully absorbed  Massage your feet for a better sleep For a craneal massage, use on your head from your neck to your temples pressing all over your scalp massage on afected area for physical fatigue, swollen feet and legs

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025 %

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporaryly relieves minor aches and pains of muscles and joints associated with

  • strains
  • bruises
  • sprains
  • arthritis
  • simple neck or back ache

Warnings

WARNINGS SECTION

For external use only

Do not

OTC - DO NOT USE SECTION

  • use on wounds or damaged skin
  • use if you are allergic to any ingredients in this product

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms persist or get worse after than 7days
  • swallowed

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

keep out reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older apply liberally onto affected area not more than 3 to 4 times daily

  • Massage evenly where needed until the gel is fully absorbed 
  • Massage your feet for a better sleep
  • For a craneal massage, use on your head from your neck to your temples pressing all over your scalp
  • massage on afected area for physical fatigue, swollen feet and legs

Other information

SPL UNCLASSIFIED SECTION

  • Store between 20-25C (68-77 F)
  • store in a cool dry place away from direct sun light

Other Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Arnica Montana Extract, Carbomer, Citrus Aurantium Dulcis (Orange) Peel Oil, DMDM Hydantoin, Glycerin, Isopropyl Myristate, Mentha Piperita (Peppermint) Oil, Mineral Oil, Panax Ginseng Root Extract, PEG-12 Dimethicone, PEG-40 Hydrogenated Castor Oil, Red 40 (CI 16035), Sodium Hydroxide, Tetrasodium EDTA, Water (Aqua)

Questions?

OTC - QUESTIONS SECTION

(954) 588-9852

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199870capsaicin 0.025 % Topical GelPSN1
199870capsaicin 0.00025 MG/MG Topical GelSCD1
199870capsaicin 0.025 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84680-529-00BIOSAVIA External Analgesic Pain Relief117.5 g in 1 BOTTLEGEL117.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84680-529BIOSAVIA EXTERNAL ANALGESIC PAIN RELIEF (CAPSAICIN) GEL [BIOSAVIA USA, LLC]1Current NDC, 1 package rows20240829_814aa66b-7719-4a29-a84e-18290367e9c7.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84680-52984680-529-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PEPPERMINT OILAV092KU4JHIACT
MINERAL OILT5L8T28FGPIACT
ASIAN GINSENGCUQ3A77YXIIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM HYDROXIDE55X04QC32IIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
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
BIOSAVIA External Analgesic Pain ReliefCAPSAICINBIOSAVIA USA, LLC814aa66b-7719-4a29-a84e-18290367e9c72024-08-28WarningsExact identifier
ndc (package): 84680-529-00
ndc (product): 84680-529
ndc11 (package): 84680052900
spl id: 20ba72da-a0c4-0f35-e063-6394a90af8e8
spl set id: 814aa66b-7719-4a29-a84e-18290367e9c7

Reported adverse events (FAERS/openFDA)#

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