NDC 58368-018 Bridge Street Hemp Full Spectrum Pain Relief

Atropa Belladonna, Arnica Montana, Black Cohosh, Stellaria Media, Caulophyllum Thalicrtoides Root, Bryonia Alba Root, Frangula Californica Bark, Hypericum Perforatum, Rhododendron Aureum Leaf, Rhododendron Tomentosum Leafy Twig

NDC Product Code 58368-018

NDC CODE: 58368-018

Proprietary Name: Bridge Street Hemp Full Spectrum 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: Atropa Belladonna, Arnica Montana, Black Cohosh, Stellaria Media, Caulophyllum Thalicrtoides Root, Bryonia Alba Root, Frangula Californica Bark, Hypericum Perforatum, Rhododendron Aureum Leaf, Rhododendron Tomentosum Leafy Twig 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

  • 58368 - Biolyte Laboratories, Llc
    • 58368-018 - Bridge Street Hemp Full Spectrum Pain Relief

NDC 58368-018-01

Package Description: 1 JAR in 1 CARTON > 56.7 g in 1 JAR

NDC Product Information

Bridge Street Hemp Full Spectrum Pain Relief with NDC 58368-018 is a a human over the counter drug product labeled by Biolyte Laboratories, Llc. The generic name of Bridge Street Hemp Full Spectrum Pain Relief is atropa belladonna, arnica montana, black cohosh, stellaria media, caulophyllum thalicrtoides root, bryonia alba root, frangula californica bark, hypericum perforatum, rhododendron aureum leaf, rhododendron tomentosum leafy twig. The product's dosage form is cream and is administered via topical form.

Labeler Name: Biolyte Laboratories, Llc

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.

Bridge Street Hemp Full Spectrum 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.

  • ATROPA BELLADONNA 3 [hp_X]/g
  • CAULOPHYLLUM THALICTROIDES ROOT 3 [hp_X]/g
  • BLACK COHOSH 3 [hp_X]/g
  • STELLARIA MEDIA 3 [hp_X]/g
  • ARNICA MONTANA 3 [hp_X]/g
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 3 [hp_X]/g
  • RHODODENDRON AUREUM LEAF 3 [hp_X]/g
  • HYPERICUM PERFORATUM 3 [hp_X]/g
  • FRANGULA CALIFORNICA BARK 3 [hp_X]/g
  • BRYONIA ALBA ROOT 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)
  • METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • ALCOHOL (UNII: 3K9958V90M)
  • CANNABIDIOL (UNII: 19GBJ60SN5)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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.

Product Labeler Information

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

Labeler Name: Biolyte Laboratories, Llc
Labeler Code: 58368
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: 02-01-2021 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: 12-31-2022 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.

Bridge Street Hemp Full Spectrum Pain Relief Product Label Images

Bridge Street Hemp Full Spectrum 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 Ingredients

Active Ingredients PurposeAll active ingredients are HPUS* & 3X potency.Belladonna, Bryonia Alba, Caulophyllum,Cimicifuga Racemosa, Hypericum, Ledum,Rhamnus Calif., Rhododendron Chrysanthum,Stellaria Media.........................................................Topical AnalgesicsArnica Montana........................................................Anti-inflammatory*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Purpose

Active Ingredients PurposeAll active ingredients are HPUS* & 3X potency.Belladonna, Bryonia Alba, Caulophyllum,Cimicifuga Racemosa, Hypericum, Ledum,Rhamnus Calif., Rhododendron Chrysanthum,Stellaria Media.........................................................Topical AnalgesicsArnica Montana........................................................Anti-inflammatory*HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.

Uses

  • UsesFor temporary relief of occasional:minor aches and pains of muscles and joints associated with simple backachearthritis strainsbruisessprainsIndications 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

WarningsFor external use only.

Ask A Doctor Before Use If

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

When Using This Product

  • 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

Stop Use And Ask A Doctor If

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

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

If Pregnant Or Breast-Feeding

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

Keep Out Of Reach Of Children

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

Directions

  • Directions:Adults and children 2 years of age and older, apply a thin layer of gel on clean skin to cover the affected area.For best results, allow gel to be aborbed 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

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

Inactive Ingredients

Inactive IngredientsEthyl Alcohol, Purified Water, Medium Chain Triglyceride (MCT) Oil, Full Spectrum CBD Distillate, Glucate DO, Carbomer, Sodium Hydroxide, Citric Acid

* Please review the disclaimer below.