FDA.reportPublic FDA data

BioMega

Manufacturer
Concept Laboratories, Inc.
Effective date
2016-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:14

Label at a glance#

ProductBioMega
Active ingredientCapsaicin
Label structure10 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains

Dosage and administration

Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age consult a physician. Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction. Gently massage into the skin until fully absorbed. Wash hands with soap and water thoroughly after each application to ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly.
  • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat Doing so can increase risk of serious burns.

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

OTC - STOP USE SECTION

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant, breast-feeding or any medical conditions exist ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult get medical attention immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
  • Gently massage into the skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort remove excess product with a soft cloth and cooking oil.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-630-9788 or visit us at www.biomegard.com

SPL UNCLASSIFIED SECTION

Manufactured for SCI Plano, TX 75024

Manufactured by: Concept Laboratories, Inc. Chicago, IL 60642

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOMEGA™

Penetrating
HEAT PAIN THERAPY Cream

with Heating Capsaicin

  • Omegas 3,6 & 9
  • With Natural Ingredients
  • Ice Pearls™ Technology
    For Hours Of Therapy

Paraben-free topical analgesic for

Arthritis • Joint Pain • Muscle Ache • Cramps

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-355-182020-01-31C16284748780-19d75b9d0-41bc-f424-e053-dadaa90a57ceBioMega™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-355-18BioMega238 g in 1 BOTTLECREAM2381

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-355BIOMEGA (CAPSAICIN) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20160923_ca938e5d-8c61-4085-9271-aba13e9395b4.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-35564058-355-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
CapsaicinS07O44R1ZMACTIB
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
LAURYL LAURATEGPW77G0937IACT
STARCH, CORNO8232NY3SJIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
ALFALFADJO934BRBDIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CYMBOPOGON SCHOENANTHUS TOP9SJI1LW39WIACT
ROSEMARYIJ67X351P9IACT
MENTHA PIPERITA LEAFA389O33LX6IACT
ASIAN GINSENGCUQ3A77YXIIACT
GINKGO19FUJ2C58TIACT
FLAX SEED4110YT348CIACT
CELOSIA ARGENTEA SEEDO1H314U8M2IACT
ACAI46AM2VJ0AWIACT
EDETATE DISODIUM7FLD91C86KIACT
EMU OIL344821WD61IACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
Ethylhexylglycerin147D247K3PIACT
Hexylene GlycolKEH0A3F75JIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETEARETH-127V4MR24V5PIACT
CETYL PALMITATE5ZA2S6B08XIACT
SODIUM HYDROXIDE55X04QC32IIACT

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
dcbfe18e-004d-460c-aa24-e52f73d4f1c7ca938e5d-8c61-4085-9271-aba13e9395b42016-09-21WarningsExact identifier
spl id: dcbfe18e-004d-460c-aa24-e52f73d4f1c7
spl set id: ca938e5d-8c61-4085-9271-aba13e9395b4

Reported adverse events (FAERS/openFDA)#

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