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NDC 54859-0513-02 Dologesic Roll-On 4 g/100mL Details
Dologesic Roll-On 4 g/100mL
Dologesic Roll-On is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Llorens Pharmaceutical International Division, Inc.. The primary component is LIDOCAINE HYDROCHLORIDE.
Product Information
| NDC | 54859-0513 |
|---|---|
| Product ID | 54859-513_4eddf947-9d0c-4e2c-968c-a948f7694681 |
| Associated GPIs | 90850060100940 43992002170920 |
| GCN Sequence Number | 080206 |
| GCN Sequence Number Description | lidocaine HCl LIQD ROLON 4 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 46917 |
| HICL Sequence Number | 001478 |
| HICL Sequence Number Description | LIDOCAINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dologesic Roll-On |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine Hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 4 |
| Active Ingredient Units | g/100mL |
| Substance Name | LIDOCAINE HYDROCHLORIDE |
| Labeler Name | Llorens Pharmaceutical International Division, Inc. |
| 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 54859-0513-02 (54859051302)
| NDC Package Code | 54859-513-02 |
|---|---|
| Billing NDC | 54859051302 |
| Package | 60 mL in 1 BOTTLE (54859-513-02) |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 81546810-85a8-45fe-b9e6-cdd02cc4c080 Details
SPL UNCLASSIFIED SECTION
Warnings
For external use only
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When using this product
- use only as directed. Read and follow all directions and warnings on this label.
- do not allow contact with eyes
- do not bandage or apply local heat (such as heating pads) to the area of use.
Stop use and ask doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| DOLOGESIC ROLL-ON
lidocaine hcl liquid |
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| Labeler - Llorens Pharmaceutical International Division, Inc. (037342305) |
Revised: 12/2020
Document Id: 4eddf947-9d0c-4e2c-968c-a948f7694681
Set id: 81546810-85a8-45fe-b9e6-cdd02cc4c080
Version: 2
Effective Time: 20201223