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NDC 00536-1357-95 Rugby Lidocaine 4 g/100g Details
Rugby Lidocaine 4 g/100g
Rugby Lidocaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is LIDOCAINE.
Product Information
| NDC | 00536-1357 |
|---|---|
| Product ID | 0536-1357_d94292f7-10fd-48bf-e053-2995a90a8472 |
| Associated GPIs | 90850060003720 |
| GCN Sequence Number | 040262 |
| GCN Sequence Number Description | lidocaine CREAM (G) 4 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 95405 |
| HICL Sequence Number | 010705 |
| HICL Sequence Number Description | LIDOCAINE |
| Brand/Generic | Generic |
| Proprietary Name | Rugby Lidocaine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine 4% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| 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 | 2024-12-31 |
Package
Package Images
NDC 00536-1357-95 (00536135795)
| NDC Package Code | 0536-1357-95 |
|---|---|
| Billing NDC | 00536135795 |
| Package | 1 TUBE in 1 BOX (0536-1357-95) / 28 g in 1 TUBE |
| Marketing Start Date | 2022-03-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d94292f7-10fc-48bf-e053-2995a90a8472 Details
Uses
SPL UNCLASSIFIED SECTION
For external use only.
When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
- When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
- Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
- Children under 12 years of age: consult a doctor.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| RUGBY LIDOCAINE
lidocaine 4% cream |
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| Labeler - Rugby Laboratories (079246066) |
Revised: 3/2022
Document Id: d94292f7-10fd-48bf-e053-2995a90a8472
Set id: d94292f7-10fc-48bf-e053-2995a90a8472
Version: 1
Effective Time: 20220302