NDC 63255-111 Hysan Pain Reliever

Methyl Salicylate, Camphor (synthetic)

NDC Product Code 63255-111

NDC 63255-111-01

Package Description: 40 mL in 1 BOTTLE, GLASS

NDC 63255-111-02

Package Description: 3 mL in 1 BOTTLE, GLASS

NDC Product Information

Hysan Pain Reliever with NDC 63255-111 is a a human over the counter drug product labeled by Hysan Pharmaceutical Co Ltd. The generic name of Hysan Pain Reliever is methyl salicylate, camphor (synthetic). The product's dosage form is oil and is administered via topical form.

Labeler Name: Hysan Pharmaceutical Co Ltd

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Hysan Pain Reliever 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.

  • METHYL SALICYLATE 37 g/100mL
  • CAMPHOR (SYNTHETIC) 10 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.

  • MENTHOL (UNII: L7T10EIP3A)
  • TURPENTINE OIL (UNII: C5H0QJ6V7F)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • ROSE OIL (UNII: WUB68Y35M7)

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: Hysan Pharmaceutical Co Ltd
Labeler Code: 63255
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: 02-01-2021 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’.

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Hysan Pain Reliever Product Label Images

Hysan Pain Reliever 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

Drug FactsActive IngredientsMethyl Salicylate 37%Camphor 10%

Otc - Purpose

PurposeExternal Analgesic

Indications & Usage

  • UsesTemporarily relieves minor aches, muscles and joint pains due to:simple backachearthritisstrainssprainsbruises

Warnings

  • Warningsexternal use onlyuse only as directed

Otc - Do Not Use

  • Do not useon opened woundon damaged skin

Otc - When Using

  • When using this productavoid contact with the eyesdo not bandage tighly

Otc - Stop Use

  • Stop use and ask a doctor ifa rash or irritation developscondition worsenssymptoms persist for more than 7 days or clears up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

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 12 years and older, apply to affected area not more than 3 to 4 times dailychildren under 12 years of age, consult a doctor before using

Other Safety Information

  • Other informationbe stored below 28°C (82°F)closed tightly after used

Inactive Ingredient

Inactive ingredientsmenthol, turpentine oil, eucalyptus oil, lavender oil, rose oil

Otc - Questions

Question or comments?(626) 354 1819 M-F 9am to 5pm

* Please review the disclaimer below.