NDC 54641-008 Flex24 Pain

Camphor Menthol

NDC Product Code 54641-008

NDC 54641-008-01

Package Description: 96 g in 1 CONTAINER

NDC Product Information

Flex24 Pain with NDC 54641-008 is a a human over the counter drug product labeled by Larasan Pharmaceutical Corporation. The generic name of Flex24 Pain is camphor menthol. The product's dosage form is cream and is administered via topical form.

Labeler Name: Larasan Pharmaceutical Corporation

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.

Flex24 Pain 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.

  • CAMPHOR (NATURAL) 3 1/100g
  • MENTHOL 10 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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • GLUCAN ENDO-1,3-.ALPHA.-GLUCOSIDASE AGN1 (UNII: 808D59AO7C)
  • BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
  • CERAMIDE NG (UNII: C04977SRJ5)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • MATRICARIA CHAMOMILLA LEAF (UNII: 6I9LN466F0)
  • CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
  • DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • LACTIC ACID, L- (UNII: F9S9FFU82N)
  • MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
  • VITAMIN A (UNII: 81G40H8B0T)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • ALCOHOL (UNII: 3K9958V90M)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STARCH, TAPIOCA (UNII: 24SC3U704I)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Larasan Pharmaceutical Corporation
Labeler Code: 54641
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: 02-22-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Flex24 Pain Product Label Images

Flex24 Pain 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

Menthol, 10%Camphor, 3%

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.

Warnings

For external use only

Do Not

• Apply to open wounds, or damaged, broken, or irritated skin

Otc - Stop Use

Stop use and ask a doctor if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Caution

• Discontinue use if excessive irritation of the skin develops• Avoid contact with the eyes and mucous membranes• Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age consult a physician immediately.

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

• Adults and children 2 years of age or older: Apply to affected area as and when required.• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) to affected area and spread smoothly over the skin with fingers.• Wash fingers that applied cream with water. Do not rub eyes with fingers until washed with water.• Children under 2 years old: consult a doctor

Inactive Ingredients

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Other Information

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

Other

Larasan Pharmaceutical Corp.1287 E. Newport Center Drive, Suite 206Deerfield Beach, FL 33442Made in USA54641-008-01

* Please review the disclaimer below.

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