FDA.reportPublic FDA data

BioMega™ Cold Pain Therapy Cream

Manufacturer
Concept Laboratories, Inc.
Effective date
2016-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:57

Label at a glance#

ProductBioMega Cold Pain Therapy
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
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 ...

Storage and handling

FLAMMABLE PRODUCT! Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Menthol 12% Topical Analgesic
Camphor 6%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.
  • If sensitive skin, ask a health professional before use. Do not use if past allergic reaction to menthol or camphor.
  • 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, burning sensation or cold sensation.
  • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

OTC - WHEN USING SECTION

When using this product

  • 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 - ASK DOCTOR 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, skin irritation or blistering of the skin.

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. Get emergency medical help if difficulty breathing, swelling of face, lips, tongue or throat, or hives.

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.

WARNING

STORAGE AND HANDLING SECTION

FLAMMABLE PRODUCT!

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate.

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOMEGA™

Triple Strength

COLD PAIN THERAPY Cream

with Cooling Menthol &
Camphor

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

8 FL OZ (237mL)

Principal Display Panel - 237 mL Bottle Label
Principal Display Panel - 237 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150970camphor 6 % / menthol 12 % Topical CreamPSN1
1150970camphor 60 MG/ML / menthol 120 MG/ML Topical CreamSCD1
1150970camphor 6 % / menthol 12 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-344-682020-01-31C16284748780-19d75b9d0-31db-f424-e053-dadaa90a57ceBioMega™ Cold Pain Therapy Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-344-68BioMega Cold Pain Therapy234 g in 1 BOTTLECREAM2341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-344BIOMEGA COLD PAIN THERAPY (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20160212_a25c9890-206b-4cdd-b5b3-63bb332cc23c.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-34464058-344-68

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
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MIACT
STARCH, CORNO8232NY3SJIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LINSEED OIL84XB4DV00WIACT
ROSEMARY OIL8LGU7VM393IACT
ACAI OILZ0W6766A2WIACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
LAURYL LAURATEGPW77G0937IACT

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
88fcb30a-3f16-46f8-a8d1-f6949a8e0425a25c9890-206b-4cdd-b5b3-63bb332cc23c2016-02-03WarningsExact identifier
spl id: 88fcb30a-3f16-46f8-a8d1-f6949a8e0425
spl set id: a25c9890-206b-4cdd-b5b3-63bb332cc23c

Reported adverse events (FAERS/openFDA)#

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