NDC 53554-030 Amrutanjan Relief Cold Rub

Camphor (synthetic), Eucalyptus Oil, And Menthol

NDC Product Code 53554-030

NDC 53554-030-05

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

NDC 53554-030-10

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

NDC Product Information

Amrutanjan Relief Cold Rub with NDC 53554-030 is a a human over the counter drug product labeled by Amrutanjan Health Care Limited. The generic name of Amrutanjan Relief Cold Rub is camphor (synthetic), eucalyptus oil, and menthol. 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 Cold Rub 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.

  • CAMPHOR (SYNTHETIC) .048 g/g
  • EUCALYPTUS OIL .012 g/g
  • MENTHOL .026 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)
  • CEDAR LEAF OIL (UNII: BJ169U4NLG)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • NUTMEG OIL (UNII: Z1CLM48948)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • THYMOL (UNII: 3J50XA376E)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)

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: part341 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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 Cold Rub 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

Camphor 4.8%Eucalyptus oil 1.2%Menthol 2.6%

Purpose

Camphor                 Cough suppressant/Topical analgesicEucalyptus oil 1.2%    Cough suppressantMenthol 2.6%             Topical analgesic

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritation associated with a coldProvides temporary relief of minor pains of muscles and joints

Warnings

  • For external use onlyDo not take by mouth or place in nostrils

Consult A Doctor Before Use If You Have

  • A persistent cough may be a seroius conditionIf cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headacheDo not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphy-sema, or if cough is accompanied by excessive phlegm (mucus) unless directed by doctor

When Using This Product

  • Do not heatDo not microwaveKeep away from fire or flameDo not add to hot water or any container where heating water. May cause splattering and result in burnsAvoid contact with eyes, 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 is presentIrritation 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 2 years and older;Rub on the throat and chest in a thick layerCover with a warm, dry cloth if desiredClothing should be loose about throat and chest to help vapors reach the nose and mouthUse up to three times daily or as directed by a doctorChildren 2 years or younger: ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

Butylated hydroxy toluene, cedar leaf oil, microcrystalline wax, nutmeg oil, petrolatum, thymol, turpentine oil.

Questions?

Call 1-888-611-6811

Principal Display Panal - 30 G Jar Cartonndc 53554-030-05Amrutanjan Relief Cold Rubtmcough Suppressant/Topical Analgesic Ointmentnet Wt: 1.05 Oz (30G)

PRINCIPAL DISPLAY PANAL - 30 g Jar Carton                                       NDC 53554-030-05AMRUTANJANRELIEF COLD RUBTMCOUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENTNET WT: 1.05 OZ (30g)PRINCIPAL DISPLAY PANAL - 50 g Jar Carton                                       NDC 53554-030-10AMRUTANJANRELIEF COLD RUBTMCOUGH SUPPRESSANT/TOPICAL ANALGESIC OINTMENTNET WT: 1.76 OZ (50g)

* Please review the disclaimer below.