Search by Drug Name or NDC
NDC 50382-0022-14 Burn 1.3; 5 mg/g; mg/g Details
Burn 1.3; 5 mg/g; mg/g
Burn is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Galentic Pharma (India) Private Limited. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.
Product Information
| NDC | 50382-0022 |
|---|---|
| Product ID | 50382-022_f3a2f68b-6f5e-9180-e053-2a95a90abdfe |
| 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 | Burn |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine Hydrochloride and Benzalkonium Chloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1.3; 5 |
| Active Ingredient Units | mg/g; mg/g |
| Substance Name | BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE |
| Labeler Name | Galentic Pharma (India) Private Limited |
| 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
NDC 50382-0022-14 (50382002214)
| NDC Package Code | 50382-022-14 |
|---|---|
| Billing NDC | 50382002214 |
| Package | 12 POUCH in 1 CARTON (50382-022-14) / .9 g in 1 POUCH |
| Marketing Start Date | 2022-06-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |