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NDC 47682-0260-12 Burn with Lidocaine 1.3; 5 mg/g; mg/g Details
Burn with Lidocaine 1.3; 5 mg/g; mg/g
Burn with Lidocaine is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.
Product Information
| NDC | 47682-0260 |
|---|---|
| Product ID | 47682-260_ec1bf303-2bef-6cc9-e053-2a95a90aba9d |
| Associated GPIs | 90859902853710 |
| GCN Sequence Number | 067841 |
| GCN Sequence Number Description | lidocaine HCl/benzalkonium chl CREAM PACK 0.5%-0.13% TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 30482 |
| HICL Sequence Number | 010610 |
| HICL Sequence Number Description | LIDOCAINE HCL/BENZALKONIUM CHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | Burn with Lidocaine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzalkonium Chloride, Lidocaine Hydrochloride |
| 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 | Unifirst First Aid Corporation |
| 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 47682-0260-12 (47682026012)
| NDC Package Code | 47682-260-12 |
|---|---|
| Billing NDC | 47682026012 |
| Package | 10 PACKET in 1 BOX (47682-260-12) / .9 g in 1 PACKET |
| Marketing Start Date | 2017-07-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 81363387-d4b1-4c3f-b67f-5017361c0fcd Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
For external use only.
Do not use
- in the eyes
- in large quantities
- over raw surfaces or blistered areas, or on deep puncture wounds, animal bites, or serious burns
- for more than 1 week unless directed by a doctor
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
MF Burn Cream with Lidocaine Label
INGREDIENTS AND APPEARANCE
| BURN WITH LIDOCAINE
benzalkonium chloride, lidocaine hydrochloride cream |
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| Labeler - Unifirst First Aid Corporation (832947092) |
Revised: 10/2022
Document Id: ec1bf303-2bef-6cc9-e053-2a95a90aba9d
Set id: 81363387-d4b1-4c3f-b67f-5017361c0fcd
Version: 13
Effective Time: 20221028