NDC 49873-620 Satohap

Camphor, Menthol, Methyl Salicylate

NDC Product Code 49873-620

NDC Code: 49873-620

Proprietary Name: Satohap Additional informationCallout TooltipWhat 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, Menthol, Methyl Salicylate Additional informationCallout TooltipWhat 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.


Code Structure
  • 49873 - Sato Pharmaceutical Co., Ltd.
    • 49873-620 - Satohap

NDC 49873-620-01

Package Description: 1 BOTTLE in 1 CARTON > 45 mL in 1 BOTTLE

NDC Product Information

Satohap with NDC 49873-620 is a a human over the counter drug product labeled by Sato Pharmaceutical Co., Ltd.. The generic name of Satohap is camphor, menthol, methyl salicylate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Sato Pharmaceutical Co., Ltd.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipWhat 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) 5 g/100mL
  • LEVOMENTHOL 6 g/100mL
  • METHYL SALICYLATE 10 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-10-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 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 ingredientsCamphorMentholMethyl salicylate

Otc - Purpose

PurposeCamphor   External analgesicMenthol   External analgesicMethyl salicylate   External analgesic

Indications & Usage

  • Uses  Temporarily relieves minor aches and pains of muscles and joints due to:simple backachearthritisstrainsbruisessprains

Warnings

WarningsFor external use onlyFlammable: Keep away from fire or flame

Otc - Do Not Use

  • Do not useon woundson irritated, broken, or damaged skinotherwise than as directed

Otc - When Using

  • When using this productavoid contact with the eyes or mucous membranesdo not bandage tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive irritation of the skin developsnausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurswhen using for pain of arthritis:   pain persists for more than 10 days   redness is present   in conditions affecting children under 12 years of ageyou experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage)

User Safety Warnings

Warning-Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied.  Read and follow all directions and warnings on this label.

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

  • Directionsadults and children 3 years of age and older: apply to the affected area not more than 3 to 4 times dailychildren under 3 years of age:  consult your physicianrefer to the above warnings; use otherwise than as directed may be dangersous

Other Safety Information

  • Other informationkeep container tightly closedstore at room temperature (20° to 25° C or 68° to 77° F)

Inactive Ingredient

Inactive ingredientsalcohol, propylene glycol, water.

* Please review the disclaimer below.

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