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NDC 61919-0577-04 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 DirectRX. The primary component is CAPSAICIN; LIDOCAINE HYDROCHLORIDE; MENTHOL; METHYL SALICYLATE.
Product Information
| NDC | 61919-0577 |
|---|---|
| Product ID | 61919-577_875fb4ec-d5f3-ad7f-e053-2995a90a6c40 |
| Associated GPIs | 90859904504220 |
| GCN Sequence Number | 073226 |
| GCN Sequence Number Description | lidocaine HCl/me sal/cap/menth OINT/APPL 4 %-27.5 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 37602 |
| HICL Sequence Number | 041636 |
| HICL Sequence Number Description | LIDOCAINE HCL/METHYL SALICYLATE/CAPSAICIN/MENTHOL |
| Brand/Generic | Generic |
| Proprietary Name | LIDOPRO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LIDOPRO |
| 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; METHYL SALICYLATE |
| Labeler Name | DirectRX |
| 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 61919-0577-04 (61919057704)
| NDC Package Code | 61919-577-04 |
|---|---|
| Billing NDC | 61919057704 |
| Package | 121 g in 1 BOTTLE (61919-577-04) |
| Marketing Start Date | 2019-04-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 875fb4ec-d5f2-ad7f-e053-2995a90a6c40 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
Ask a doctor before use if
you are allergic to any ingredients, PABA, aspirin products or sulfa
When using this product
avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.
If pregnant or breast feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.
Store
at 20○C - 25○C (68○F - 77○F)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
Made in the U.S.A.
Patent Pending
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| LIDOPRO
lidopro ointment |
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| Labeler - DirectRX (079254320) |
| Registrant - DirectRX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DirectRX | 079254320 | relabel(61919-577) | |