NDC 82075-425 Pain Relief Stick

Menthol

NDC Product Code 82075-425

NDC 82075-425-25

Package Description: 1 CYLINDER in 1 CARTON > 50 g in 1 CYLINDER

NDC Product Information

Pain Relief Stick with NDC 82075-425 is a a human over the counter drug product labeled by Sagely Enterprises Inc.. The generic name of Pain Relief Stick is menthol. The product's dosage form is stick and is administered via topical form.

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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 Relief Stick 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.

  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

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: Sagely Enterprises Inc.
Labeler Code: 82075
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: 07-02-2021 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 - 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.

Pain Relief Stick Product Label Images

Pain Relief Stick 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 Ingredient

Menthol 10%

Purpose

Menthol 10%...................Topical analgesic

Uses

  • Temporarily relieves the minor aches and pains of muscles and joints associated with:arthritissprainsmuscle strainsbruises

Warnings

For external use only.

Otc - Do Not Use

  • Do not useon wounds, or damaged, broken, or irritated skinwith a heating pad

Otc - When Using

  • When using this productavoid contact with eyes or mucous membranesdo not bandage tightly

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

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.

Directions

  • Use only as directedAdults and children over 12 years:apply a thin layer to affected areamassage into painful arearepeat as necessary, but no more than 3 to 4 times dailyChildren 12 years or younger: ask a doctor.

Other Information

  • Store in a cool, dry place

Inactive Ingredients

Capric/Caprytic Triglyceride, Ethylhexyt Patmttate, Candelilla (Euphorbia Cerifera) WaJI., Coconut (Cocos Nucifera) Oil, Camphor, Lavender (Lavanduta Hybrida) Oil, Peppermint (Mentha Piperita) Oil, Shea (Butyrospermum Parkii) Butter, Cocoa (Theobroma Cacao) Butter, Kokum (Garcinia tndica) Butter, Mango (Mangffera tndica) Seed Butter, Avocado (Persea Gratissima) Oil, Boswellia Serrata Resin Extract, Amica Montana (Flower) Extract, Magnesium Chloride

* Please review the disclaimer below.