Label: FLANAX BACK PAIN RELIEF- lidocaine patch
- NDC Code(s): 27854-333-01
- Packager: Belmora LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 9, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only.
Do not use if pouch is damaged or opened.
Do not use • More than 1 patch on your body at a time or on cut, irritated or swollen skin • On puncture wounds • For more than one week without consulting a doctor
When using this product
• Use only as directed. Read and follow all directions and warnings on this pouch
• Rare cases of serious burns have been reported with products of this type
• Do not apply to wounds or damaged, broken or irritated skin
• Do not allow contact with the eyes and mucous membranes
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use
• Do not use at the same time as other topical analgesics
• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patchStop use and ask a doctor if
• Condition worsens • Redness is present • Irritation develops
• Symptoms persist for more than 7 days or clear up and occur again within a few days
• You experience signs of skin injury, such as pain, swelling, or blistering where the product was appliedIf pregnant or breast-feeding, ask a health professional before use.
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Directions
Adults and children over 12 years: • Clean and dry affected area • Carefully remove backing film from patch • Apply one patch to affected area • Do not use more than 2 patches in 24 hours unless, directed by a doctor.
Children under 12 years: ask a doctor.
How to apply
• Remove backing from patch by firmly grasping both ends and gently pull backing to separate it in the middle.
• Carefully remove one portion of backing from patch and apply exposed portion of patch to affected area.
• Once exposed portion of patch is positioned, remove remaining backing to completely apply patch to affected area. - Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
FLANAX BACK PAIN RELIEF
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27854-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) EDETATE DISODIUM (UNII: 7FLD91C86K) KAOLIN (UNII: 24H4NWX5CO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TARTARIC ACID (UNII: W4888I119H) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POVIDONE K90 (UNII: RDH86HJV5Z) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27854-333-01 1 in 1 POUCH; Type 0: Not a Combination Product 12/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/15/2021 Labeler - Belmora LLC (112753244)
