FDA.reportPublic FDA data

Bio-Relief H

Manufacturer
SSG Ventures Inc
Effective date
2021-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:39:53

Label at a glance#

ProductBio-Relief
Active ingredientMENTHOL
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%.

Purpose: Topical Analgesic

OTC - PURPOSE SECTION

COOLING GEL W 10% MENTHOL IN ARNICA TINCTURE

INDICATIONS & USAGE SECTION

FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN

FAST ACTING COOLING PAIN RELIEF

WARNINGS SECTION

FOR EXTERNAL USE ONLY

FLAMMABLE, KEEP AWAY FROM FLAME

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

DOSAGE & ADMINISTRATION SECTION

Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.

INACTIVE INGREDIENT SECTION

Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.

OTHER SAFETY INFORMATION

Store in a cool and dry place with lid closed tightly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN2
259249menthol 0.1 MG/MG Topical GelSCD2
259249menthol 10 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-003-012023-01-30C16284748780-1f386c649-a348-0266-e053-dadaa90a7c1aBio-Relief
81376-004-012023-01-30C16284748780-1f386c649-a348-0266-e053-dadaa90a7c1aBio-Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-003-01Bio-Relief89 mL in 1 TUBE, WITH APPLICATORGEL892
81376-004-01Bio-Relief H89 mL in 1 TUBE, WITH APPLICATORGEL892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-003BIO-RELIEF (MENTHOL) GEL BIO-RELIEF H (MENTHOL) GEL [SSG VENTURES INC]2Legacy NDC, 1 package rows20210422_c081f351-324c-cb7e-e053-2a95a90ae660.zip
81376-004BIO-RELIEF (MENTHOL) GEL BIO-RELIEF H (MENTHOL) GEL [SSG VENTURES INC]2Legacy NDC, 1 package rows20210422_c081f351-324c-cb7e-e053-2a95a90ae660.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81376-00381376-003-01
81376-00481376-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ARNICA MONTANAO80TY208ZWIACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL ALCOHOLND2M416302IACT
TEA TREE OILVIF565UC2GIACT
BOSWELLIA SACRA BARK1UK28DX728IACT
FRANKINCENSE OIL67ZYA5T02KIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVENDER OILZBP1YXW0H8IACT
MENTHOLL7T10EIP3AACTIB
TEA TREE OILVIF565UC2GIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL ALCOHOLND2M416302IACT
FRANKINCENSE OIL67ZYA5T02KIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVENDER OILZBP1YXW0H8IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
MENTHOLL7T10EIP3AACTIB

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
c081dbd9-1729-6070-e053-2995a90a28e8c081f351-324c-cb7e-e053-2a95a90ae6602021-04-21WarningsExact identifier
spl id: c081dbd9-1729-6070-e053-2995a90a28e8
spl set id: c081f351-324c-cb7e-e053-2a95a90ae660

Reported adverse events (FAERS/openFDA)#

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