NDC 49873-068 Satohap

Methyl Salicylate, Dl-camphor, L-menthol

NDC Product Code 49873-068

NDC 49873-068-02

Package Description: 70 mL in 1 CANISTER

NDC Product Information

Satohap with NDC 49873-068 is a a human over the counter drug product labeled by Sato Pharmaceutical Co., Ltd.. The generic name of Satohap is methyl salicylate, dl-camphor, l-menthol. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1249174 and 1249176.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 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.

  • ALCOHOL (UNII: 3K9958V90M)

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: 11-03-2006 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.

Satohap Product Label Images

Satohap 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

Otc - Active Ingredient

Active ingredientsdl-Camphor 5%

l-Menthol 4%

Methyl salicylate 10%

Otc - Purpose

Purposedl-Camphor    External analgesic

l-Menthol        External analgesic

Methyl salicylate    External analgesic

Indications & Usage

Uses   temporary relieves minor aches and pains of muscles and joints due to

■ backache   ■ arthritis   ■ strains   ■ bruises   ■sprains


For external use only

Otc - Do Not Use

Do not use on wounds or on damaged skin

Otc - When Using

When using this product
■ avoid contact with the eyes

■ do not bandage tightly

Otc - Stop Use

Stop use and ask a doctor if
■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

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

Safe Handling Warning

Warnings-contents under pressure
■ do not puncture or incinerate container.

■ do not expose to heat or store at temperatures above 120 degrees F.

Dosage & Administration

Directions■ adults and children 2 years of age and over: Hold can upright and spray until wet. Apply to affected area not more than 3 to 4 times daily.

■ children under 2 years of age: Do not use and ask a doctor.

Inactive Ingredient

Inactive ingredientsfragrance, phenylethyl alcohol, alcohol, propylene glycol, LPG

* Please review the disclaimer below.