NDC 27854-400 Flanax Liniment

Methyl Salicylate, Menthol, Capsaicin

NDC Product Code 27854-400

NDC 27854-400-01

Package Description: 1 TUBE in 1 CARTON > 30 g in 1 TUBE

NDC Product Information

Flanax Liniment with NDC 27854-400 is a a human over the counter drug product labeled by Belmora Llc. The generic name of Flanax Liniment is methyl salicylate, menthol, capsaicin. The product's dosage form is liniment and is administered via topical form.

Labeler Name: Belmora Llc

Dosage Form: Liniment - A solution or mixture of various substances in oil, alcoholic solutions of soap, or emulsions intended for external application.

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.

Flanax Liniment 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 28 g/100g
  • MENTHOL, UNSPECIFIED FORM 10 g/100g
  • CAPSAICIN .025 g/100g

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.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • GINGER (UNII: C5529G5JPQ)
  • GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
  • ZANTHOXYLUM AMERICANUM BARK (UNII: A4KL1HMZ7T)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

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: Belmora Llc
Labeler Code: 27854
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: 09-11-2020 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.

Flanax Liniment Product Label Images

Flanax Liniment 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 Ingredients

Methyl Salicylate 28%Menthol 10%Capsaicin 0.025%

Purpose

Topical Analgesic

Indications & Usage

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, sprains, strains and bruises

Warnings

Warnings: For external use only. Do not use if you are allergic to any of the active or inactive ingredients. Do not use: on wounds damaged,broken, or irritated skin. With a heating pad. Immediately before or after taking a bath or shower. Stop use and ask a doctor if: Conditionworsens. Symptoms persist for more than 7 days or clear up and occur again within a few days. Skin irritation occurs. When using this product, do not: heat, microwave, add to hot water or any container with heating water. May cause splattering and result in burns. Avoid contact with lips, eyes, nose and any mucous membranes at all times. Do not bandage.

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.

Dosage & Administration

Directions: Adults and children 12 years of age and older: Apply to affected area not more than 3-4 times daily. A temporary burning maybe felt when applied, but usually disappears with continued use. Wash hands thoroughly after use to avoid spreading liniment to the eyes or othersensitive areas of the body. If applying liniment to the hands wait 30 minutes before washing hands. Initial pain relief is usually noted within 1-2weeks. If condition does not improve in 4 weeks discontinue use of this product. Children under 12 years of age: consult doctor before use.

Storage And Handling

Other Information: Store at room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredient

Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Glyceryl Stearate, Peg-100 Stearate, Cetearyl Alcohol and Polysorbate 60, Propylene Glycol, Stearyl Alcohol, Phenoxyethanol, Benzoic Acid, Ethylhexylglycerin, Glycereth-2 Cocoate, Hydroxypropyl Methyl Cellulose, Acrylates/C10-30alkyl Acrylate Crosspolymer, Salix Alba (Willow) Bark Extract, Zingiber Officinale (Ginger) Root Extract, Gaultheria Procumbens (Wintergreen) Leaf Extract, Zanthoxylum Americanum Bark Extract, Pinus Pinaster Bark/Bud Extract, Boswellia Serrata Gum

* Please review the disclaimer below.