Biofreeze Ultraflex
2655974b-a67d-9f07-e063-6294a90a54e8
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient: Lidocaine 4% Purpose: Pain Relieving Patch
Medication Information
Warnings and Precautions
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 and Usage
Uses
For the temporary relief of pain
Dosage and Administration
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
Description
Active ingredient: Lidocaine 4% Purpose: Pain Relieving Patch
Uses
Uses
For the temporary relief of pain
Section 50565-1
Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.
Section 51727-6
Inactive ingredients:
Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene,
Styrene/Isoprene/Styrene Block Copolymer
Section 51945-4
Section 53413-1
Questions or comments? 1-866-682-4639
Section 55106-9
Active ingredient:
Lidocaine 4%
Purpose:
Pain Relieving Patch
Section 60561-8
Other information
store at 20-25°C (68-77°F)
store in a cool dry place away from direct sunlight
Structured Label Content
Uses
Uses
For the temporary relief of pain
Indications and Usage (34067-9)
Uses
For the temporary relief of pain
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
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.
Section 50565-1 (50565-1)
Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.
Section 51727-6 (51727-6)
Inactive ingredients:
Butylated Hydroxytoluene, Glyceryl Hydrogenated Rosinate, Mineral Oil, Polyisobutylene,
Styrene/Isoprene/Styrene Block Copolymer
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? 1-866-682-4639
Section 55106-9 (55106-9)
Active ingredient:
Lidocaine 4%
Purpose:
Pain Relieving Patch
Section 60561-8 (60561-8)
Other information
store at 20-25°C (68-77°F)
store in a cool dry place away from direct sunlight
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:45.990292 · Updated: 2026-03-14T23:08:02.764471