NDC 72809-103 Zandu Balm

Menthol And Methyl Salicylate

NDC Product Code 72809-103

NDC 72809-103-11

Package Description: 1 JAR in 1 BOX > 7.74 g in 1 JAR

NDC 72809-103-12

Package Description: 1 JAR in 1 BOX > 21.5 g in 1 JAR

NDC Product Information

Zandu Balm with NDC 72809-103 is a a human over the counter drug product labeled by Emami Limited. The generic name of Zandu Balm is menthol and methyl salicylate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Emami 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.

Zandu 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, UNSPECIFIED FORM 160 mg/g
  • METHYL SALICYLATE 100 mg/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.

  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)

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.
  • 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: Emami Limited
Labeler Code: 72809
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: 11-21-2019 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.

Zandu Balm Product Label Images

Zandu 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 16%Methyl salicaylate 10%

Ask A Doctor Before Use If You Have

  • Redness over the affected areaSensitive skin

When Using This Product

  • Use only as directedAvoid contact with the eyes and mucous membranes.Do not apply to wounds, damaged or irritated skin.Do not bandage tightly

Keep Out Of Reach Of Children To Avoid Accidental Ingestion

  • If swallowed, get medical help or contact a poison control centre immediately

If Pregnant Or Breast Feeding

If pregnant or breast feeding, or if you have sensitive skin, ask a healthcare professional before use.

Uses

  • For the temporary relief of minor aches and pains of
  • Muscles and joints associated with
  • Simple backacheBruisesStrainsArthritisSprains

Questions

Call (Emami customer care office Ph: 033 6613 6264)

Stop Use And Ask A Doctor If

  • Condition worsens or symptoms persist for more than 7 daysSymptoms clear up and occur again within a few days

Other Information

Store below 30°C (86° F) in a cool and dry place, away from direct heat and sunlight.

Warning

For external use only

Inactive Ingredients

Light mineral oil, Microcrystalline wax, Paraffin

Directions

  • Adults and children 12 years and older: Apply generously in a thin layer on the affected area not more than 3 to 4 times daily; massage gently on the affected areaChildren under 12 years of age: consult a physician.

Purpose

Topical analgesic

Dosage & Administration

Dosage- Balm (Ointment)Administration-Topical (For external use only)

* Please review the disclaimer below.