NDC 66761-324 Tiger Balm Pain Relieving Hydrogel Large

Camphor (synthetic), Levomenthol, And Capsicum

NDC Product Code 66761-324

NDC CODE: 66761-324

Proprietary Name: Tiger Balm Pain Relieving Hydrogel Large What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Camphor (synthetic), Levomenthol, And Capsicum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 66761 - Haw Par Healthcare Ltd.
    • 66761-324 - Tiger Balm Pain Relieving Hydrogel

NDC 66761-324-04

Package Description: 1 POUCH in 1 BOX > 4 PATCH in 1 POUCH

NDC Product Information

Tiger Balm Pain Relieving Hydrogel Large with NDC 66761-324 is a a human over the counter drug product labeled by Haw Par Healthcare Ltd.. The generic name of Tiger Balm Pain Relieving Hydrogel Large is camphor (synthetic), levomenthol, and capsicum. The product's dosage form is patch and is administered via topical form.

Labeler Name: Haw Par Healthcare Ltd.

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.

Tiger Balm Pain Relieving Hydrogel Large 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) 230 mg/1
  • LEVOMENTHOL 70 mg/1
  • CAPSICUM 46 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.

  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITOL (UNII: 506T60A25R)
  • TARTARIC ACID (UNII: W4888I119H)

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: Haw Par Healthcare Ltd.
Labeler Code: 66761
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: 01-01-2017 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 - 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.

Tiger Balm Pain Relieving Hydrogel Large Product Label Images

Tiger Balm Pain Relieving Hydrogel Large 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

Other

Drug Facts

Otc - Purpose

Active IngredientsPurposeDL-Camphor 230 mg/patchTopical AnalgesicL-Menthol 70 mg /patchTopical AnalgesicCapsicum Extract 46 mg/patchTopical Analgesic

Uses

For temporary relief of pains.

Warnings

FOR EXTERNAL USE ONLY

When Using This Product

  • Use only as directedDo not get into eyes or on mucous membranesDo not apply to wounds, damaged or irritated skinDo not bandage or cover with any type of wrap except clothingDo not use with a heating pad or apply external heatDo not use 1 hour prior to bathing or within 30 minutes after bathing

Stop Use And Ask A Doctor If

  • Condition worsensSevere skin irritation occursPain persists for more than 7 daysSymptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times dailyChildren under 12 years, consult doctor before useHow to apply: Clean and dry affected areaCut open pouch and remove patchRemove protective film and apply directly to area of painApply to affected area not more than 3 times dailyWash hands with soap after applying patchReseal pouch containing unused patches

Other Information

This product may cause allergic reaction on some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredients

Carboxymethylcellulose Sodium, Eucalyptus Oil, Glycerin, Mentha Oil, Methyl Acrylate and 2-Ethylhexyl Acrylate Copolymer, Purified Water, Polysorbate 80, PVA Solution, Silicon Dioxide, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Monooleate, Sorbitol Solution, Tartaric Acid

* Please review the disclaimer below.