Sano Ti Amo Relief And Repair Pain Relief
Menthol, Unspecified Form, Camphor (synthetic)
Sano Ti Amo, Llc
Human Otc Drug
NDC 80216-111Sano Ti Amo Relief And Repair Pain Relief also known as Menthol, Unspecified Form, Camphor (synthetic) is a human otc drug labeled by 'Sano Ti Amo, Llc'. National Drug Code (NDC) number for Sano Ti Amo Relief And Repair Pain Relief is 80216-111. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Sano Ti Amo Relief And Repair Pain Relief drug includes Camphor (synthetic) - 3 mg/mL Menthol, Unspecified Form - 13.4 mg/mL . The currest status of Sano Ti Amo Relief And Repair Pain Relief drug is Active.
Drug Information:
| Drug NDC: | 80216-111 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Sano Ti Amo Relief And Repair Pain Relief |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Menthol, Unspecified Form, Camphor (synthetic) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sano Ti Amo, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CAMPHOR (SYNTHETIC) - 3 mg/mL
MENTHOL, UNSPECIFIED FORM - 13.4 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 08 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part348 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Sano Ti Amo, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 5TJD82A1ET
L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 80216-111-02 | 60 mL in 1 CONTAINER (80216-111-02) | 08 Oct, 2019 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose topical analgesic topical analgesic
Product Elements:
Sano ti amo relief and repair pain relief menthol, unspecified form, camphor (synthetic) menthol, unspecified form menthol, unspecified form camphor (synthetic) camphor (synthetic) water isopropyl palmitate sunflower oil stearyl alcohol glycerin ppg-30 cetyl ether cetyl alcohol .gamma.-aminobutyric acid dimethyl sulfone echinacea purpurea flowering top echinacea purpurea root echinacea angustifolia root astragalus propinquus root baptisia tinctoria bacopa monnieri whole calendula officinalis flower arnica montana phenoxyethanol ethylhexylglycerin peppermint oil shea butter cannabis sativa seed oil pyridoxine cannabis sativa whole tea tree oil
Indications and Usage:
Use for the temporary relief of aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains
Warnings:
Warnings: external use only avoid contact with eyes, open cuts, damaged or irritated skin or sensitive areas. do not use if allergic to any of the ingredients. those taking coumadin (blood thinner or warfarin type medications) or have kidney issues/failure should consult their physician before using. do not use with other topical products. do not use if pregnant or nursing. do not bandage. do not apply heat. keep out of reach of children. if swallowed get medical help or contact poison control center immediately.
Dosage and Administration:
Directions adults â 18 and over apply and gently massage into painful joints and or muscles. repeat as needed, no more than 4 times per day. wash hands after each use.
Package Label Principal Display Panel:
Principal display panel â 2 oz container label sano ti amo llc relief & repair⢠pain relief cream extra strength penetrates quickly fast & long lasting relief 12 restorative botanicals doctor recommended relief from the inside out net wt. 2 oz. (60 ml) principal display panel â 2 oz container label
Further Questions:
Questions & comments: 330-940-2129 www.sanotiamo.com deerfield, ohio 44411