NDC 71918-001 Timing Pain Savior Cool Herbal Patch

Menthol, Methyl Salicylate

NDC Product Code 71918-001

NDC CODE: 71918-001

Proprietary Name: Timing Pain Savior Cool Herbal Patch 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: Menthol, Methyl Salicylate 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

  • 71918 - Timing Pharmaceutical Co., Ltd Pabp Branch
    • 71918-001 - Timing Pain Savior Cool Herbal Patch

NDC 71918-001-05

Package Description: 5 PATCH in 1 BOX > 6 g in 1 PATCH

NDC Product Information

Timing Pain Savior Cool Herbal Patch with NDC 71918-001 is a a human over the counter drug product labeled by Timing Pharmaceutical Co., Ltd Pabp Branch. The generic name of Timing Pain Savior Cool Herbal Patch is menthol, methyl salicylate. The product's dosage form is patch and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2054076.

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.

Timing Pain Savior Cool Herbal Patch 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.


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.

  • ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • PAEONIA LACTIFLORA WHOLE (UNII: N44H57P7WG)
  • SCROPHULARIA NINGPOENSIS ROOT (UNII: HC0FB6P85R)
  • CHINESE CINNAMON (UNII: WS4CQ062KM)
  • SESAME OIL (UNII: QX10HYY4QV)
  • RHUBARB (UNII: G280W4MW6E)
  • MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)
  • REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
  • HUMAN HAIR, CARBONIZED (UNII: UJ56P3G411)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • ASAFETIDA (UNII: W9FZA51AS1)
  • MYRRH (UNII: JC71GJ1F3L)
  • ROSIN (UNII: 88S87KL877)
  • ZINC OXIDE (UNII: SOI2LOH54Z)
  • BASIC YELLOW 5 (UNII: 07BP340B4T)
  • DIRECT BLUE 2 (UNII: EE5HVP9RA8)

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: Timing Pharmaceutical Co., Ltd Pabp Branch
Labeler Code: 71918
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: 01-20-2018 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.

Timing Pain Savior Cool Herbal Patch Product Label Images

Timing Pain Savior Cool Herbal Patch 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   4%Methyl Salicylate  0.5%

Purpose

Menthol          Topical AnalgesicMethyl Salicylate      Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children over 12 years of age.Wear one Cool Herbal Patch up to 4-6 hours.Repeat as necessary, but not more than 3 times daily.Children 12 years or younger, consult a doctor.

Warning

For External Use Only.

Ask A Doctor Or Pharmacist Before Use If You Are

Pregnant.taking other medications.

When Using This Product

Use only as directed.Do not bandage tightly or use with a heating pad.Avoid contact with eyes and mucous membranes.Do not apply to wounds or damaged, broken or irritated skin.

Stop Use And Ask A Doctor If

Condition worsens.redness is present.irritation develops.symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

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

Other Information

Keep package tightly closed after opening.Store below 20℃ (68 ℉) in a dry place away from direct sunlight.

Inactive Ingredients

ANGELICA DAHURICA ROOT, ANGELICA SINENSIS ROOT, PAEONIA LACTIFLORA WHOLE, SCROPHULARIA NINGPOENSIS ROOT, CHINESE CINNAMON, SESAME OIL, RHUBARB, MOMORDICA COCHINCHINENSIS SEED, REHMANNIA GLUTINOSA ROOT, CARBONIZED HUMAN HAIR, FRANKINCENSE OIL, ASAFETIDA, MYRRH, ROSIN, ZINC OXIDE, BASIC YELLOW 5, DIRECT BLUE 2

* Please review the disclaimer below.