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NDC 68788-7629-01 LidoPro .000325; .04; .1; .275 g/g; g/g; g/g; g/g Details
LidoPro .000325; .04; .1; .275 g/g; g/g; g/g; g/g
LidoPro is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Preferred Pharmaceuticals. The primary component is CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.
Product Information
| NDC | 68788-7629 |
|---|---|
| Product ID | 68788-7629_ca945e8c-014c-431c-838c-d39e08ff8eb3 |
| Associated GPIs | 90859904504220 |
| 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 | LidoPro |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capsaicin, Lidocaine, Menthol, and Methyl Salicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | .000325; .04; .1; .275 |
| Active Ingredient Units | g/g; g/g; g/g; g/g |
| Substance Name | CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE |
| Labeler Name | Preferred Pharmaceuticals |
| 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 68788-7629-01 (68788762901)
| NDC Package Code | 68788-7629-1 |
|---|---|
| Billing NDC | 68788762901 |
| Package | 121 g in 1 BOTTLE (68788-7629-1) |
| Marketing Start Date | 2020-03-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f4ec0b40-88c9-42ca-97e9-bae5e2e38577 Details
SPL UNCLASSIFIED SECTION
Methemoglobinemia
Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Uses:
Warnings
For external use only
Do not use
- •
- on open wounds, cuts, damaged or infected skin
- •
- with bandage or a heating pad
- •
- if condition worsens or symptoms persists for more than 7 days
- •
- excessive skin irritation occurs
When using this product
- •
- avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.
Directions
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.
For Questions or Comments
Please Email [email protected]
Manufactured for
Terrain Pharmaceuticals
Reno, NV 89501
Relabeled By: Preferred Pharmaceuticals Inc.
Made in the U.S.A.
Patent Pending
Principal Display Panel
INGREDIENTS AND APPEARANCE
| LIDOPRO
capsaicin, lidocaine, menthol, and methyl salicylate ointment |
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| Labeler - Preferred Pharmaceuticals (791119022) |
| Registrant - Preferred Pharmaceuticals (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Preferred Pharmaceuticals | 791119022 | RELABEL(68788-7629) | |