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NDC 27854-0333-01 Flanax Back Pain Relief 4 g/1 Details
Flanax Back Pain Relief 4 g/1
Flanax Back Pain Relief is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Belmora LLC. The primary component is LIDOCAINE.
MedlinePlus Drug Summary
Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.
Related Packages: 27854-0333-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch
Product Information
| NDC | 27854-0333 |
|---|---|
| Product ID | 27854-333_bb1ea19e-ae02-4164-ae9c-7323d5132ff0 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Flanax Back Pain Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/1 |
| Substance Name | LIDOCAINE |
| Labeler Name | Belmora LLC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 27854-0333-01 (27854033301)
| NDC Package Code | 27854-333-01 |
|---|---|
| Billing NDC | 27854033301 |
| Package | 1 PATCH in 1 POUCH (27854-333-01) |
| Marketing Start Date | 2021-12-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 46d33346-e582-4af1-b81a-feca7033dceb Details
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 patch
Stop 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 applied
If pregnant or breast-feeding, ask a health professional before use.
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
INGREDIENTS AND APPEARANCE
| FLANAX BACK PAIN RELIEF
lidocaine patch |
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| Labeler - Belmora LLC (112753244) |