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NDC 63135-0581-10 TOPICAINE 5 5 g/100g Details
TOPICAINE 5 5 g/100g
TOPICAINE 5 is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by ESBA LABORATORIES INC.. The primary component is LIDOCAINE.
Product Information
| NDC | 63135-0581 |
|---|---|
| Product ID | 63135-581_008977e2-cdc2-9f04-e063-6394a90a1dbf |
| Associated GPIs | 89200025004020 |
| GCN Sequence Number | 051771 |
| GCN Sequence Number Description | lidocaine GEL (GRAM) 5 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 19125 |
| HICL Sequence Number | 010705 |
| HICL Sequence Number Description | LIDOCAINE |
| Brand/Generic | Brand |
| Proprietary Name | TOPICAINE 5 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LIDOCAINE 5% |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | g/100g |
| Substance Name | LIDOCAINE |
| Labeler Name | ESBA LABORATORIES INC. |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | n/a |
Package
NDC 63135-0581-10 (63135058110)
| NDC Package Code | 63135-581-10 |
|---|---|
| Billing NDC | 63135058110 |
| Package | 1 TUBE in 1 BOX (63135-581-10) / 10 g in 1 TUBE |
| Marketing Start Date | 2003-04-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |