NDC 66902-111 Sano Ti Amo Relief And Repair Pain Relief

Menthol, Unspecified Form, Camphor (synthetic)

NDC Product Code 66902-111

NDC CODE: 66902-111

Proprietary Name: Sano Ti Amo Relief And Repair Pain Relief What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Menthol, Unspecified Form, Camphor (synthetic) What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 66902 - Natural Essentials, Inc.
    • 66902-111 - Sano Ti Amo Relief And Repair Pain Relief

NDC 66902-111-02

Package Description: 60 mL in 1 CONTAINER

NDC Product Information

Sano Ti Amo Relief And Repair Pain Relief with NDC 66902-111 is a a human over the counter drug product labeled by Natural Essentials, Inc.. The generic name of Sano Ti Amo Relief And Repair Pain Relief is menthol, unspecified form, camphor (synthetic). The product's dosage form is cream and is administered via topical form.

Labeler Name: Natural Essentials, Inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sano Ti Amo Relief And Repair Pain Relief Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MENTHOL, UNSPECIFIED FORM 13.4 mg/mL
  • CAMPHOR (SYNTHETIC) 3 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PPG-30 CETYL ETHER (UNII: 00C2W8NVII)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65)
  • ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)
  • ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
  • ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)
  • BAPTISIA TINCTORIA (UNII: 5K1UO2888Y)
  • BACOPA MONNIERI WHOLE (UNII: DUB5K84ELI)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
  • PYRIDOXINE (UNII: KV2JZ1BI6Z)
  • TEA TREE OIL (UNII: VIF565UC2G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Natural Essentials, Inc.
Labeler Code: 66902
FDA Application Number: part348 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 10-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sano Ti Amo Relief And Repair Pain Relief Product Label Images

Sano Ti Amo Relief And Repair Pain Relief Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

DRUG FACTS     NDC # 66902-111-02

Active Ingredients

Camphor .3%
Menthol 1.5%

Purpose

Topical Analgesic
Topical Analgesic

Use

  • For the temporary relief of aches and pains of muscles and joints associated with:
  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains

Warnings:

  • External Use Only
  • Avoid contact with eyes, open cuts, damaged or irritated skin or sensitive areas.

Otc - Do Not Use

  • Do not use if allergic to any of the ingredients.

Otc - Ask Doctor

  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center immediately.

Directions

  • Adults – 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.

Other Information

* Store at room temperature, protect from excessive heat

Inactive Ingredients

Water, Isopropyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Stearyl Alcohol, Glycerine, Hetoxol C, Cetyl Alcohol, Gamma-aminobutyric Acid, Dimethyl Sulfone (MSM), Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Echinacea, Astragalus Propinquus Root, Phenoxyethanol, Ethylhexylglycerin, Mentha Piperita (Peppermint) Oil, Bacopa Monnieri Extract, Baptisia Tinctoria, Butyrospermum Parkii (Shea Butter), Hemp Seed Oil, Vitamin B6, Hemp Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

* Please review the disclaimer below.