FDA.reportPublic FDA data

BIOTEMPER

Manufacturer
Scientific Solutions Global, LLC
Effective date
2018-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:30

Label at a glance#

ProductBIOTEMPER
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure11 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

• Adults and children 2 years 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

Storage and handling

• store in a cool and dry place with lid closed tightly

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only
Flammable keep away from fire or flame
When using this product • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skin
Stop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days
If pregnant or breast-feeding, ask a health professional before use

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years 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 Ingredients

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 Information

STORAGE AND HANDLING SECTION

• store in a cool and dry place with lid closed tightly

Questions or Comments?

OTC - QUESTIONS SECTION

Call us at: 1(516) 543-3376 M-F 9am-6pm EST or E-mail:info@biotemper.com

SPL UNCLASSIFIED SECTION

DEEP PENETRATING GEL

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

MADE WITH HERBAL & HOMEOPATHIC INGREDIENTS

NO NSAIDs, IBUPROFEN, ASPIRIN, OR SALICYLATE

BIOTEMPER.COM

DISTRIBUTED BY:

SCIENTIFIC SOLUTIONS GLOBAL, LLC

CARLE PLACE, NY

PROUDLY MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioTGel1BioTGel1BioTGel2BioTGel2

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
71718-333-012020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-022020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-042020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-052020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-072020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-092020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-112020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-132020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-152020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71718-333-01BIOTEMPER118 mL in 1 JARGEL1181
71718-333-02BIOTEMPER2 in 1 PACKAGEGEL21
71718-333-02BIOTEMPER118 mL in 1 JARGEL1181
71718-333-04BIOTEMPER118 mL in 1 TUBEGEL1181
71718-333-05BIOTEMPER2 in 1 PACKAGEGEL21
71718-333-05BIOTEMPER118 mL in 1 TUBEGEL1181
71718-333-07BIOTEMPER237 mL in 1 BOTTLE, PUMPGEL2371
71718-333-09BIOTEMPER452 mL in 1 BOTTLE, PUMPGEL4521
71718-333-11BIOTEMPER946 mL in 1 BOTTLE, PUMPGEL9461
71718-333-13BIOTEMPER1893 mL in 1 BOTTLE, PUMPGEL18931
71718-333-15BIOTEMPER3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71718-333BIOTEMPER (MENTHOL) GEL [SCIENTIFIC SOLUTIONS GLOBAL, LLC]1Legacy NDC, 11 package rows20180213_667fb0b9-6095-4c6c-8731-a4f888951ecc.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71718-33371718-333-01, 71718-333-02, 71718-333-04, 71718-333-05, 71718-333-07, 71718-333-09, 71718-333-11, 71718-333-13, 71718-333-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
FRANKINCENSER9XLF1R1WMIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
FRANKINCENSE OIL67ZYA5T02KIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
ISOPROPYL ALCOHOLND2M416302IACT
LAVENDER OILZBP1YXW0H8IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TEA TREE OILVIF565UC2GIACT
THYMOL3J50XA376EIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

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
158b958a-1a99-4f82-931b-c5c83e320ad2667fb0b9-6095-4c6c-8731-a4f888951ecc2018-01-29WarningsExact identifier
spl id: 158b958a-1a99-4f82-931b-c5c83e320ad2
spl set id: 667fb0b9-6095-4c6c-8731-a4f888951ecc

Reported adverse events (FAERS/openFDA)#

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