NDC 53554-020 Amrutanjan Relief Strong Pain Balm

Menthol, Methyl Salicylate

NDC Product Code 53554-020

NDC 53554-020-03

Package Description: 1 JAR in 1 BLISTER PACK > 9 g in 1 JAR

NDC 53554-020-05

Package Description: 1 JAR in 1 CARTON > 30 g in 1 JAR

NDC 53554-020-10

Package Description: 1 JAR in 1 CARTON > 50 g in 1 JAR

NDC Product Information

Amrutanjan Relief Strong Pain Balm with NDC 53554-020 is a a human over the counter drug product labeled by Amrutanjan Health Care Limited. The generic name of Amrutanjan Relief Strong Pain Balm is menthol, methyl salicylate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Amrutanjan Health Care Limited

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Amrutanjan Relief Strong Pain Balm 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 .15 g/g
  • METHYL SALICYLATE .15 g/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.

  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Amrutanjan Health Care Limited
Labeler Code: 53554
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: 12-22-2020 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.

Amrutanjan Relief Strong Pain Balm 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

Menthol 15.0%Methyl Salicylate  15%

Purpose

Menthol                    Topical analgesicMethyl Salicylate      Topical analgesic

Uses

  • Temporarily relieves pain associated with headache, cold, body ache and nasal congestionProvides temporary relief of minor pains of muscles and joints

Warnings

  • For External use onlyAvoid contact with eyesDo not use otherwise than as directed

When Using This Product

  • Do not heatDo not microwaveDo not use near an open flameDo not add to hot water or any container where heating water. May cause splattering and result in burnsAvoid contact with wounds, mucous membranes, broken or irritated skinDo not bandage tightly or use with heating pad

Stop Use Of This Product And Consult A Doctor If

  • Condition worsensRedness or irritation developsSymptoms persist for more than 7 days or clear up and occur again within a few days or is accompanied by fever, rash, or persistent headaches

Directions

  • See important warning "When using this product"Adults and children over 12 yearsApply and gently massage over the affected areaRepeat 2- 3 times daily, or as directed by a doctorChildren 12 years or younger: ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

Butylated hydroxy toluene, cetostreayl alcohol, microcrystalline wax, paraffin, petrolatum

Questions?

Call 1-888-611-6811

Ndc 53554-020-05Amrutanjan Relief Strong Pain Balmtmpain Relieving Ointmentnet Wt: 1.05 Oz (30G)

PRINCIPAL DISPLAY PANEL - 30 g Jar Carton

* Please review the disclaimer below.