Biofreeze Ultraflex

Manufacturer
Reckitt Benckiser LLC
Effective date
2026-06-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-06-04 05:10:13

Label at a glance#

ProductBiofreeze Ultraflex
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Uses For the temporary relief of pain

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION


Active ingredient:
Lidocaine 4%

Purpose:

Pain Relieving Patch

Uses

OTC - PURPOSE SECTION


Uses
For the temporary relief of pain

WARNINGS SECTION


Warnings
For external use only.


Do not use
􀂄 more than 1 patch on your body at a time or with other topical anesthetics at the same time
􀂄 on wounds, damaged skin, rashes, or swollen skin
􀂄 with a heating pad or apply local heat to the area of use
􀂄 in large quantities, particularly over raw surfaces or blistered areas


When using this product
􀂄 use only as directed
􀂄 do not bandage tightly
􀂄 avoid contact with the eyes or on mucous membranes
􀂄 dispose of used patch in manner that always keeps product away from children and pets.
Used patches still contain the drug product that can produce serious adverse effects if a
child or pet chews or ingests this patch.


Stop use and ask a doctor if
􀂄 the condition for which this preparation is used persists or if a rash, redness or
irritation develops
􀂄 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again
within few days
􀂄 you experience pain, swelling or blistering of the skin


If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.

INDICATIONS & USAGE SECTION


Uses
For the temporary relief of pain

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.

DOSAGE & ADMINISTRATION SECTION


Directions
􀂄 adults and children 12 years of age and older: Clean and dry affected area, cut open pouch
and remove patch from protective film by first peeling back center film. Apply exposed patch
to affected area. Carefully remove remaining film while pressing the patch to skin and leave in
place for up to 8 hours. (see images on carton)
􀂄 use 1 patch at a time and not more than 3 to 4 times daily
􀂄 children under 12 years of age: consult a physician
􀂄 wash hands after use with cool water

OTHER SAFETY INFORMATION


Other information
􀂄 store at 20-25°C (68-77°F)
􀂄 store in a cool dry place away from direct sunlight

INACTIVE INGREDIENT SECTION


Inactive ingredients:
Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene,
Styrene/Isoprene/Styrene Block Copolymer

OTC - QUESTIONS SECTION

Questions or comments? 1-866-682-4639

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

LabelLabel

carton labelcarton label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130731124444967GTIN-13: 0731124444967
EAN-13: 0731124444967
GTIN-12: 731124444967
UPC-A: 731124444967
GTIN storage (14 digits): 00731124444967
59316-899 carton label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59316-89959316-899-04, 59316-899-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-05-15full-release2026-06-01 01:57:39

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
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
ndc (package): 59316-899-07
ndc (package): 59316-899-04
ndc (product): 59316-899
ndc11 (package): 59316089904
ndc11 (package): 59316089907
spl id: 5348f92e-a770-de13-e063-6294a90adbcc
spl set id: 2655974b-a67d-9f07-e063-6294a90a54e8

Reported adverse events (FAERS/openFDA)#

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