Otc - Active Ingredient
Active ingredient:
Lidocaine 4%
Purpose:
Pain Relieving Patch
Biofreeze Ultraflex Patch
FDA Label NDC 59316-899
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rb Health (us) Llc for the product Biofreeze Ultraflex (NDC 59316-899). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, uses, warnings, indications & usage, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - 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
Otc - Questions
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