NDC 48951-2144 Borago Lavender

Borago Lavender

NDC Product Code 48951-2144

NDC 48951-2144-5

Package Description: 120 g in 1 TUBE

NDC Product Information

Borago Lavender with NDC 48951-2144 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Borago Lavender is borago lavender. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Borago Lavender 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.


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.

  • ALCOHOL (UNII: 3K9958V90M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SORBIC ACID (UNII: X045WJ989B)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • WATER (UNII: 059QF0KO0R)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)

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: Uriel Pharmacy Inc.
Labeler Code: 48951
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: 12-09-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Borago Lavender Product Label Images

Borago Lavender 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

Indications & Usage

Directions: FOR TOPICAL USE ONLY.

Dosage & Administration

Apply to skin as needed. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: 100 gm contains: 20 gm Aesculus (Horse chestnut seed) 1X, 20 gm Borago (Borage) 1X,

12 gm Melilotus (Yellow sweet clover) 1X

Inactive Ingredient

Inactive Ingredients: Distilled water, Organic cane alcohol, Witch Hazel distillate, Magnesium aluminum silicate,

Lavender oil, Xanthan gum, Sorbic acid, Tea tree oil, Grapefruit seed extract

Otc - Purpose

Uses: Temporarily relieves symptoms of varicose veins and leg cramps.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: FOR EXTERNAL USE ONLY.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist,

or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes.
SHAKE WELL BEFORE USE.

Otc - Questions

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

shopuriel.com

* Please review the disclaimer below.