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NDC 00536-1202-07 Rugby PAIN RELIEF PATCHES 4 g/100g Details
Rugby PAIN RELIEF PATCHES 4 g/100g
Rugby PAIN RELIEF PATCHES is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY LABORATORIES. 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: 00536-1202-07Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch
Product Information
| NDC | 00536-1202 |
|---|---|
| Product ID | 0536-1202_d4f0fb50-31e5-19a8-e053-2a95a90ad557 |
| Associated GPIs | 90850060005920 |
| GCN Sequence Number | 023447 |
| GCN Sequence Number Description | lidocaine ADH. PATCH 4 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 60050 |
| HICL Sequence Number | 010705 |
| HICL Sequence Number Description | LIDOCAINE |
| Brand/Generic | Generic |
| Proprietary Name | Rugby PAIN RELIEF PATCHES |
| 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/100g |
| Substance Name | LIDOCAINE |
| Labeler Name | RUGBY LABORATORIES |
| 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 00536-1202-07 (00536120207)
| NDC Package Code | 0536-1202-07 |
|---|---|
| Billing NDC | 00536120207 |
| Package | 30 PATCH in 1 CARTON (0536-1202-07) / 9 g in 1 PATCH |
| Marketing Start Date | 2021-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.89288 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | LIDOCAINE PAIN RELIEF 4% PATCH |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL b34e40c8-a257-46cf-9399-f55df9b4102d Details
Active Ingredients
Dosage and Administration
Directions Adults and children over 12 years:
■ clean and dry affected area
■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
■ use one patch for up to 12 hours. Children under 12 years of age: consult a physician.
When using this product
■ use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ 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 consult a doctor
Do not Use
Keep out of reach of children and pets.
Other Safety Information
Inactive Ingredients
Questions
Warnings
For external use only.
Do not use
■ more than one patch on your body at a time
■ on cut, irritated or swollen skin
■ on puncture wounds
■ for more than one week without consulting a doctor
■ if you are allergic to any active or inactive ingredients
■ if pouch is damaged or opened.
When using this product
use only as directed
■ read and follow all directions and warnings on this carton
■ do not allow contact with the eyes
■ do not use at the same time as other topical analgesics
■ do not bandage tightly or apply local heat (such as heating pads) to the area of use
■ do not microwave
■ 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.
Directions
Directions Adults and children 12 years of age and over:
■ clean and dry affected area
■ carefully remove backing from patch starting at a corner
■ apply sticky side of patch to affected area
■ use one patch for up to 12 hours.
- Discard patch after single use
- Children under 12 years of age: consult a physician.
Other safety information
Inactive Ingredients
INGREDIENTS AND APPEARANCE
| RUGBY PAIN RELIEF PATCHES
lidocaine patch |
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| Labeler - RUGBY LABORATORIES (079246066) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Foshan Aqua Gel Biotech Co., Ltd., | 529128763 | manufacture(0536-1202) | |