NDC 72625-135 Ultra Vedic

Pain Relief

NDC Product Code 72625-135

NDC 72625-135-03

Package Description: 1 CARTON in 1 PATCH > 3 PATCH in 1 CARTON

NDC Product Information

Ultra Vedic with NDC 72625-135 is a a human over the counter drug product labeled by Pharmaneek, Inc.. The generic name of Ultra Vedic is pain relief. The product's dosage form is patch and is administered via topical form.

Labeler Name: Pharmaneek, Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Ultra Vedic 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 78.75 mg/1
  • METHYL SALICYLATE 78.75 mg/1
  • CAMPHOR (NATURAL) 78.75 mg/1

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.

  • MINERAL OIL (UNII: T5L8T28FGP)

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: Pharmaneek, Inc.
Labeler Code: 72625
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: 03-01-2019 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.

Ultra Vedic 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

Menthol 10%Wintergreen Oil 7%Camphor 7%

Purpose

Topical AnalgesicTopical AnalgesicTopical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache | Arthritis | Sprains | Strains | Bruises.

Warnings

For External Use Only Do not use otherwise than as directed.

Do Not Use

  • On open wounds, cuts, eyes, and faceWith a heating pad

When Using This Product

  • Avoid contact with eyes and mucous membranesDo not bandage tightly

Ask Your Doctor Before Use If You Have

  • Redness over the affected areahave sensitive skinare pregnant or breast-feeding

Stop Use And Ask Your Doctor

  • If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few daysIf abnormal skin irritation occurs after usage

Keep Out Of Reach Of Children

If swallowed, seek medical help or contact a Poison Control Center right away.

Directions

  • For use by Adults and Children 12 year of age and olderApply to the affected area no more than 2 times a dayDry skin completely at application site area, before applying the patchOpen pouch and remove patchPeel off protective film and apply sticky side to affected areaIf applied on hairy skin, remove gently using mild warm waterPatch once used, cannot be re-pasted or reusedDispose properly after useChildren under 12 years of age, consult a doctor

Other Information

  • Store at room temperature below 80°F (27°C)

Inactive Ingredient

Adhesive Plaster

Questions?

Call 1-866-241-6885info@pharmaneek.comwww.ultravedic.com

* Please review the disclaimer below.

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