Search by Drug Name or NDC
NDC 69440-0007-15 Siterol 3.99; 1 g/100g; g/100g Details
Siterol 3.99; 1 g/100g; g/100g
Siterol is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Binger Consulting Corporation. The primary component is LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 69440-0007 |
|---|---|
| Product ID | 69440-007_b553bb21-4705-45e1-a49b-336b022680db |
| Associated GPIs | 90859902885920 |
| 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 | Siterol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lidocaine HCL, Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | PATCH |
| Route | TOPICAL |
| Active Ingredient Strength | 3.99; 1 |
| Active Ingredient Units | g/100g; g/100g |
| Substance Name | LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | Binger Consulting 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 | 2024-12-31 |
Package
Package Images
NDC 69440-0007-15 (69440000715)
| NDC Package Code | 69440-007-15 |
|---|---|
| Billing NDC | 69440000715 |
| Package | 15 PATCH in 1 BOX (69440-007-15) / 100 g in 1 PATCH |
| Marketing Start Date | 2015-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1ef21407-5fd2-4349-8d4f-af3b13dab476 Details
Warnings
For external use only
Do not use
• if pregnant or breastfeeding, consult physician prior to use
• in large quantities, particularly over raw surfaces or blistered areas
When using this product
• use only as directed • do not bandage tightly • avoid contact with eyes
• do not apply to open wounds or damaged skin
Stop use and ask a doctor if
• symptoms persist for more than seven days, discontinue use and consult physician
• swallowed, consult physician
Directions
SPL UNCLASSIFIED SECTION
Other ingredients aloe barbadensis leaf (aloe vera juice) gel, aqua (deionized water), arnica montana extract, boswellia serrata extract, camellia sinensis leaf (green tea) extract, carbomer, ethylhexylglycerin, glycerin, isopropyl myristate, PEG-8, phenoxyethanol, polysorbate-80, sodium lauryl sulfate, triethanolamine, FD C blue 1, FD C yellow 5
INGREDIENTS AND APPEARANCE
| SITEROL
lidocaine hcl, menthol patch |
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||
| Labeler - Binger Consulting Corporation (079635976) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Active Intelligence, LLC | 080416593 | manufacture(69440-007) | |