NDC 62699-3313 Pain Terminator Analgesic

Topical Analgesic

NDC Product Code 62699-3313

NDC 62699-3313-1

Package Description: 500 g in 1 JAR

NDC 62699-3313-2

Package Description: 12 BOX in 1 BOX > 1 TUBE in 1 BOX > 50 g in 1 TUBE

NDC 62699-3313-3

Package Description: 5 g in 1 TUBE

NDC Product Information

Pain Terminator Analgesic with NDC 62699-3313 is a a human over the counter drug product labeled by Nan Me Pharmaceutical Co., Ltd.. The generic name of Pain Terminator Analgesic is topical analgesic. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nan Me Pharmaceutical Co., Ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Pain Terminator Analgesic 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.

  • MENTHOL .02 g/g
  • METHYL SALICYLATE .005 g/g

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.

  • JOJOBA OIL (UNII: 724GKU717M)
  • PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V)
  • ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
  • CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)
  • PYRITIDIUM (UNII: 0PFV70949S)
  • DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU)
  • MYRRH (UNII: JC71GJ1F3L)
  • LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO)
  • ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB)
  • ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1)
  • ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU)
  • GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B)
  • PINELLIA TERNATA ROOT (UNII: G9AET085M5)
  • SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9)
  • CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS)
  • CHINESE CINNAMON (UNII: WS4CQ062KM)
  • DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • SCHORL TOURMALINE (UNII: 173O8XLY6T)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Nan Me Pharmaceutical Co., Ltd.
Labeler Code: 62699
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: 02-23-2009 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".

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Pain Terminator Analgesic 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 - Purpose

Topical Analgesic

Active Ingredients

Menthol 2% - Topical Analgesic, Wintergreen Oil 0.5% - Topical Analgesic

Indications

  • For the temporary relief of minor aches of muscles and joints associated with:simple backachearthritisstrainsbruisessprains

Directions

Apply to affected area not more than 2 to 3 times daily. Try on small area first to test forsensitivity. Children under 4 years of age should not use, unless consulted by a physician.

Warnings

  • FOR EXTERNAL USE ONLY

Otc - Do Not Use

  • Avoid contac with eyes or mucous membranes.Do not apply to wounds or damaged or irritated skin.Do not use if skin is sensitive, or have allergies to any ingredients in this product. Discontinue use and consult a doctor if signs of irritation or rash appear.In case of ingestion, seek professional assistance or contact a Poison Control Center immediately.

Otc - Pregnancy Or Breast Feeding

  • If pregnant or breast feeding consult a doctor before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Other Ingredients

Jojoba oil, paeonia veitchii radix, angelicae sinensis radix, carthami flos, pyritum, draconis resina, myrrha, ligustici rhizoma, acanthopanacis cortex, achyranthis radix, atractylodis rhizoma, gentianae macrophyllae radix, pinelliae tuber, sausureae radix, cnidii monnieri fructus, cinnamomum cortex, dioscoreae tokoro rhizoma, jasmine oil, tourmaline.

Pain Terminator Sleeve For 50G Tube.

PT Cream Sleeve for 50g Tube.jpg

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