NDC 73807-001 Simi-tree Natural Pain Relief

Menthol

NDC Product Code 73807-001

NDC 73807-001-50

Package Description: 50 g in 1 BOTTLE, DISPENSING

NDC Product Information

Simi-tree Natural Pain Relief with NDC 73807-001 is a a human over the counter drug product labeled by Higgins And Phillips Innovations Inc.. The generic name of Simi-tree Natural Pain Relief is menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Higgins And Phillips Innovations 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.

Simi-tree Natural 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 3 g/100g

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.

  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • WHEAT GERM OIL (UNII: 14C97E680P)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • JUNIPER BERRY OIL (UNII: SZH16H44UY)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
  • CINNAMON OIL (UNII: E5GY4I6YCZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • .ALPHA.-TOCOPHEROL SUCCINATE, DL- (UNII: 7VJE08U49E)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CLOVE OIL (UNII: 578389D6D0)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • OLEIC ACID (UNII: 2UMI9U37CP)

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: Higgins And Phillips Innovations Inc.
Labeler Code: 73807
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: 07-15-2020 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: 12-31-2021 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.

Simi-tree Natural Pain Relief Product Label Images

Simi-tree Natural 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

Active Ingredient(S)

Menthol 3% w/w. Purpose: Counter Irritant; Temporarily relieves aches and pains of muscles and joints associated with arthritis, backache, strains and sprains.

Purpose

Counter Irritant; Temporarily relieves aches and pains of muscles and joints associated with arthritis, backache, strains and sprains.

Direction For Use

DIRECTIONS FOR USE: Adults, adolescents, and children ≥ 2 years: Apply 1 to 4 pumps evenly to targeted area(s) up to 4 times per day; For children (2 - 12 years) applications should be supervised by an adult.

Warnings

For external use only; Avoid contact with eyes and mucous membranes;DURATION OF USE: Consult a health care practitioner for use beyond 7 days. CAUTIONS AND WARNINGS: Call a Poison Control Center immediately if overdose or accidental ingestion occurs; Store in airtight, light-resistant container at room temperature; Stop use and consult a health care practitioner if symptoms worsen, re-occur within a few days; KNOWN ADVERSE REACTIONS: If you experience pain, swelling or blistering, stop use and get medical help right away; Stop use if hypersensitivity/allergy, rashes and/or burning discomfort occur.

Do Not Use

Do not apply to wounds or damaged skin; Do not tightly bandage; Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn. Safety sealed for your protection, do not use if seal is broken or missing

Known Adverse Reactions

KNOWN ADVERSE REACTIONS: If you experience pain, swelling or blistering, stop use and get medical help right away; Stop use if hypersensitivity/allergy, rashes and/or burning discomfort occur

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions For Use

DIRECTIONS FOR USE: Adults, adolescents, and children ≥ 2 years: Apply 1 to 4 pumps evenly to targeted area(s) up to 4 times per day

Other Information

Store in airtight, light-resistant container at room temperature;

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Boswellia serrata (Frankincense) Essential Oil, Cetyl Alcohol, Cinnamomum zeylanicum (Ceylon Cinnamon) Bark Essential Oil, dl-Alpha-Tocopheryl Succinate, Ethylhexylglycerin, Eucalyptus polybractea (Eucalyptus) Essential Oil, Eugenia caryophyllus (Clove) Bud Essential Oil, Glycerin, Glyceryl Stearate, Grape Seed Oil, Hydroxylated Lecithin, Juniperus communis (Juniper) Fruit Essential Oil, Lavandula angustifolia (Lavender) Essential Oil, Magnesium Aluminum Silicate, Myristica fragrans (Nutmeg) Kernel Essential Oil, Oenothera biennis (Evening Primrose) Oil, Oleic Acid, Olive Oil, PEG-100 Stearate, Phenoxyethanol, Purified water, Rosmarinus officinalis (Rosemary) Leaf Essential Oil, Stearic Acid, Trolamine, Wheat Germ Oil, Xanthan Gum, Zingiber officinale (Ginger) Root Oil

* Please review the disclaimer below.