Biotemper

Manufacturer
Biotemper | Pharmacena Labs, LLC
Effective date
2016-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:40

Label at a glance#

ProductBiotemper
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure10 sections

Storage and handling

Other information: Store in a cool and dry place with the lid closed tightly.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 10%.

Camphor USP 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children: If ingested, seek medical help and contact a Poison Control Center immediately.

INDICATIONS & USAGE SECTION

Uses : Soothing temporary relief from minor aches and pains associated with • sore muscles • strains • joint discomfort • arthritis • backache • tendonitis

WARNINGS SECTION

Warning: For external use only.

Flammable: Keep away from excessive heat or open flames.

Ask a doctor before using if you have: Sensitive skin If pregnant or breast feeding: Ask a health professional before use.

When using this product: • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin. • Do not use with other ointments, creams, sprays or liniments. • Do not apply to irritated skin or if excessive irritation develops. • Do not bandage. • Wash hands after use with cool water • Do not use with heating pad or device.
Stop use and ask a doctor if: Condition worsens or if symptoms persist for more than 7 days or clear up and reoccur.

DOSAGE & ADMINISTRATION SECTION

Directions: Adult and Children 2 years age and older: Rub a thin film over affected areas not more than 4 times daily: Massage not necessary Children under 2 years of age: Consult physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Vera Oil, Arnica Flower Tincture, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Propylene Glycol USP

STORAGE AND HANDLING SECTION

Other information: Store in a cool and dry place with the lid closed tightly.

SPL UNCLASSIFIED SECTION

NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE

FOR ARTHRITIS/BACK PAIN/ BRUISES/SORE MUSCLES/ SPORTS SPRAINS

Shake well before each use. Apply by rolling in only one direction.

Do not use in a circular motion

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1802859camphor 2 % / menthol 10 % Topical LotionPSN1
1802859camphor 20 MG/ML / menthol 100 MG/ML Topical LotionSCD1
1802859camphor 2 % / menthol 10 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70744-516-012020-01-31C16284748780-19d75b9d0-1648-f424-e053-dadaa90a57ceBiotemper - Herbal Pain Relief Therapy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70744-516-01Biotemper89 mL in 1 BOTTLELIQUID891

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70744-516BIOTEMPER (MENTHOL, CAMPHOR) LIQUID [BIOTEMPER]1Legacy NDC, 1 package rows20160729_2bbc1a15-c95b-4a0b-a898-0e87a3f429e2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70744-51670744-516-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
b5f83006-4dd3-4bad-b163-b8293d27c8e52bbc1a15-c95b-4a0b-a898-0e87a3f429e22016-06-30WarningsExact identifier
spl id: b5f83006-4dd3-4bad-b163-b8293d27c8e5
spl set id: 2bbc1a15-c95b-4a0b-a898-0e87a3f429e2

Reported adverse events (FAERS/openFDA)#

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