FDA.reportPublic FDA data

Biotemper Foot Cream

Manufacturer
SSG Ventures Inc
Effective date
2021-04-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:53

Label at a glance#

ProductBiotemper
Active ingredientMENTHOL
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%.......................Topical Analgesic

OTC - PURPOSE SECTION

TOPICAL ANALGESIC WITH 10% MENTHOL

INDICATIONS & USAGE SECTION

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

FAST ACTING COOLING PAIN RELIEF

WARNINGS SECTION

FOR EXTERNAL USE ONLY

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. 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259249menthol 10 % Topical GelPSN1
259249menthol 0.1 MG/MG Topical GelSCD1
259249menthol 10 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81376-001-012023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-001-022023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-001-032023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-001-042023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-001-052023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-001-062023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper
81376-002-012023-01-30C16284748780-1f386c649-f69c-0266-e053-dadaa90a7c1aBiotemper

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-001-01Biotemper113 mL in 1 JARGEL1131
81376-001-02Biotemper452 mL in 1 BOTTLE, PUMPGEL4521
81376-001-03Biotemper1900 mL in 1 BOTTLE, PUMPGEL19001
81376-001-04Biotemper89 mL in 1 TUBE, WITH APPLICATORGEL891
81376-001-05Biotemper118 mL in 1 BOTTLE, SPRAYGEL1181
81376-001-06Biotemper118 mL in 1 TUBEGEL1181
81376-002-01Biotemper Foot Cream57 mL in 1 JARGEL571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-001BIOTEMPER (MENTHOL) GEL BIOTEMPER FOOT CREAM (MENTHOL) GEL [SSG VENTURES INC]1Legacy NDC, 6 package rows20210422_c0808c11-50ac-6536-e053-2995a90a886f.zip
81376-002BIOTEMPER (MENTHOL) GEL BIOTEMPER FOOT CREAM (MENTHOL) GEL [SSG VENTURES INC]1Legacy NDC, 1 package rows20210422_c0808c11-50ac-6536-e053-2995a90a886f.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
81376-00181376-001-01, 81376-001-02, 81376-001-03, 81376-001-04, 81376-001-05, 81376-001-06
81376-00281376-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ARNICA MONTANAO80TY208ZWIACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
MENTHOLL7T10EIP3AACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL ALCOHOLND2M416302IACT
TEA TREE OILVIF565UC2GIACT
BOSWELLIA SACRA BARK1UK28DX728IACT
FRANKINCENSE OIL67ZYA5T02KIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVENDER OILZBP1YXW0H8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ARNICA MONTANAO80TY208ZWIACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
MENTHOLL7T10EIP3AACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL ALCOHOLND2M416302IACT
TEA TREE OILVIF565UC2GIACT
BOSWELLIA SACRA BARK1UK28DX728IACT
FRANKINCENSE OIL67ZYA5T02KIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVENDER OILZBP1YXW0H8IACT
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT

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
c0808c11-50ad-6536-e053-2995a90a886fc0808c11-50ac-6536-e053-2995a90a886f2021-04-21WarningsExact identifier
spl id: c0808c11-50ad-6536-e053-2995a90a886f
spl set id: c0808c11-50ac-6536-e053-2995a90a886f

Reported adverse events (FAERS/openFDA)#

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