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NDC 70645-0735-10 Lidocaine 3.5 g/1 Details
Lidocaine 3.5 g/1
Lidocaine is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by 7T Pharma 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: 70645-0735-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch
Product Information
| NDC | 70645-0735 |
|---|---|
| Product ID | 70645-735_a7269ad8-0e90-4c95-ae46-99ad2cc3e26c |
| Associated GPIs | 90850060005917 |
| GCN Sequence Number | 080520 |
| GCN Sequence Number Description | lidocaine ADH. PATCH 3.5 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 47388 |
| HICL Sequence Number | 010705 |
| HICL Sequence Number Description | LIDOCAINE |
| Brand/Generic | Generic |
| Proprietary Name | Lidocaine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 3.5 |
| Active Ingredient Units | g/1 |
| Substance Name | LIDOCAINE |
| Labeler Name | 7T Pharma 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 | 2023-12-31 |
Package
Package Images
NDC 70645-0735-10 (70645073510)
| NDC Package Code | 70645-735-10 |
|---|---|
| Billing NDC | 70645073510 |
| Package | 2 POUCH in 1 CARTON (70645-735-10) / 5 PATCH in 1 POUCH |
| Marketing Start Date | 2021-08-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL eca766bf-0d27-48ad-b9bb-1d84b642e5fb Details
Uses
Warnings
For external use only
Do not use
• More than 1 patch on your body at a time or on irritated or swollen skin
• On wounds, damaged or infected skin
• On eyes, mouth, genitals or other mucous membranes
When using this product
• Use only as directed. Read and follow all directions and warnings on this carton and packet insert.
• Do not allow contact with the eyes.
• 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 or anesthetics.
• Dispose of used patch in a 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 and consult a physician:
• If condition or pain worsens
• If you are allergic to any of the ingredients in this product
• If symptoms persist for more than 7 days, or symptoms clear up and occur again within a few days
• If you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
• If using concurrently with any other external pain-relieving products
If pregnant or breast-feeding, ask a health professional before use.
Directions
Adults and children 12 years of age and older:
Apply 1 patch topically to affected area of intact skin for up to 12 hours a day
- Clean and dry the affected area.
- Open pouch and remove one patch. Remove backing from patch.
- Carefully apply patch directly to affected area. Apply immediately after removal from the protective envelope.
- Wash hands with soap and water after handling the patches.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Consult a physician
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| LIDOCAINE
lidocaine patch |
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| Labeler - 7T Pharma LLC (080220022) |