BIOFREEZE ULTRAFLEX- lidocaine patch

Biofreeze Ultraflex by

Drug Labeling and Warnings

Biofreeze Ultraflex by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:
Lidocaine 4%

Purpose:

Pain Relieving Patch

Uses

Uses
For the temporary relief of pain

WARNINGS

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

Uses
For the temporary relief of pain

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets. If swallowed, get medical help or contact a
Poison Control Center right away.

DOSAGE & 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

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

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

QUESTIONS

Questions or comments? 1-866-682-4639

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOFREEZE ULTRAFLEX 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59316-899
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.04 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59316-899-04	4 in 1 CARTON	01/15/2025
1		2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 59316-899-07	1 in 1 POUCH	01/15/2025
2		2 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/15/2025

Labeler - RB Health (US) LLC (081049410)