NDC 49873-621 Satohap Cool And Hot Pads

Camphor, Capsaicin, Menthol

NDC Product Code 49873-621

NDC 49873-621-01

Package Description: 1 POUCH in 1 BOX > 5 mL in 1 POUCH

NDC Product Information

Satohap Cool And Hot Pads with NDC 49873-621 is a a human over the counter drug product labeled by Sato Pharmaceutical Co., Ltd.. The generic name of Satohap Cool And Hot Pads is camphor, capsaicin, menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Sato Pharmaceutical Co., 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.

Satohap Cool And Hot Pads 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.

  • CAPSAICIN .04 g/100mL
  • LEVOMENTHOL 6 g/100mL
  • CAMPHOR (SYNTHETIC) 3.1 g/100mL

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.

  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • WATER (UNII: 059QF0KO0R)
  • METHYL ACRYLATE (UNII: WC487PR91H)
  • SORBITOL (UNII: 506T60A25R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
  • ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TALC (UNII: 7SEV7J4R1U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MALIC ACID (UNII: 817L1N4CKP)
  • TRIETHYLENE GLYCOLDIMETHACRYLATE (UNII: 14I47YJ5EY)

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: Sato Pharmaceutical Co., Ltd.
Labeler Code: 49873
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: 12-18-2020 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: 12-31-2022 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.

Satohap Cool And Hot Pads Product Label Images

Satohap Cool And Hot Pads 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 3.1%Capsaicin 0.025%Menthol 6%

Purpose

External analgesicExternal analgesicExternal analgesic

Uses

  • For the temporary relief of minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains

Warnings

For external use only

Do Not Use

  • On irritated or damaged skinon wounds

Ask A Doctor Or Pharmacist Before Use If You Have

  • Any concerns about using this product

When Using This Product

  • Avoid contact with the eyes or mucus membranesdo not bandage tightlydo not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns)

Stop Use And Ask A Doctor If

  • Condition worsenssymptoms persists for more than 7 dayssymptoms clear up and occur again within a few daysexcessive irritation of the skin developesnausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs.you feel actual pain or experience a blistering or burning after application (it is normal to feel awarming or cooling sensation)when using for pain or arthritis:pain persists for more than 10 daysredness is presentin conditions affecting children under 12 years of age

Keep Out Of Reach Of Children.

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

Directions

  • Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area. do not use more than 2 patches per day.Children under 4 years of age: Consult a doctor.

Other Information

  • Keep pouch tightly closedkeep product protected from heat

Inactive Ingredients

Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

* Please review the disclaimer below.