NDC 73507-001 Allevatio Therapeutic Pain Gel

Aesculus Hipp., Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Ruta Grav., Arnica Montana, Calendula

NDC Product Code 73507-001

NDC CODE: 73507-001

Proprietary Name: Allevatio Therapeutic Pain Gel 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: Aesculus Hipp., Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Ruta Grav., Arnica Montana, Calendula 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

  • 73507 - Plant2product, Inc.

NDC 73507-001-01

Package Description: 56.7 g in 1 BOTTLE, PUMP

NDC Product Information

Allevatio Therapeutic Pain Gel with NDC 73507-001 is a a human over the counter drug product labeled by Plant2product, Inc.. The generic name of Allevatio Therapeutic Pain Gel is aesculus hipp., caulophyllum, cimicifuga racemosa, hypericum, ledum, rhamnus calif., ruta grav., arnica montana, calendula. The product's dosage form is gel and is administered via topical form.

Labeler Name: Plant2product, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Allevatio Therapeutic Pain Gel 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.

  • CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/g
  • RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]/g
  • ARNICA MONTANA 3 [hp_X]/g
  • CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X]/g
  • BLACK COHOSH 3 [hp_X]/g
  • FRANGULA CALIFORNICA BARK 3 [hp_X]/g
  • HORSE CHESTNUT 3 [hp_X]/g
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 3 [hp_X]/g
  • HYPERICUM PERFORATUM 3 [hp_X]/g

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)
  • MYRISTYL ALCOHOL (UNII: V42034O9PU)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • .BETA.-D-GLUCOPYRANOSE (UNII: J4R00M814D)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: Plant2product, Inc.
Labeler Code: 73507
Marketing Category: UNAPPROVED HOMEOPATHIC - 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: 01-30-2020 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.

Allevatio Therapeutic Pain Gel 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 Ingredients

All active ingredients are HPUS* & 3X potency.Aesculus Hipp., Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Ruta Grav.Arnica MontanaCalendula*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Purpose

All active ingredients are HPUS* & 3X potency.Aesculus Hipp., Caulophyllum, Cimicifuga Racemosa, Hypericum, Ledum, Rhamnus Calif., Ruta Grav. ................. Topical AnalgesicsArnica Montana ................. Anti-inflammatoryCalendula ................. Relief for bruising and soreness*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Uses

  • For temporary relief of occasional:minor aches and pains of muscles and joints associated with
  • Simple backachearthritisstrainsbruisessprainsIndications are based on homeopathic materia medica not clinical tests.Indications are based on theories of homeopathy that are not supported by scientific evidence and most modern allopathic medical professionals.

Warnings

For external use only.

Otc - Ask Doctor

Ask a doctor before use if: taking a prescription drug or have a serious medical condition

Otc - When Using

  • When using this product: Avoid contact with eyes or mucous membranes
  • Do not use with other ointments, creams, or spraysDo not apply over large areas of the body or bandageDo not use with heating pad or device

Otc - Stop Use

Stop use and ask a doctor if: conditions worsen, or if symptoms persist for more than seven (7) days, or clear up and reoccur.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding: Ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 years age and older, apply a thin layer of gel on clean skin to cover the affected area.
  • For best results, allow gel to be absorbed into the skin;
  • Do not rub in.Apply at the onset of symptoms, or every 15 minutes for the first hour, but not more than 6 times daily.Children under 2 years of age: Consult a doctor

Other Information

  • Store in a cool, dry place.Avoid direct sunlight.Tamper-evident for your protection. Use only if safety seal is intact.

Inactive Ingredients

Cannabidiol (CBD), *Caprylyl Glycol, Carbomer, Citric Acid, *Ethylhexylglycerin, *Lauryl Glucoside, *Myristyl, Glucoside, *Polyglyceryl-6-Laurate, Potassium Sorbate, Purified Water, Sodium Hydroxide*
Plant Based Ingredients

* Please review the disclaimer below.