NDC 35192-039 Kanjo Pain Relief Gel

Menthol

NDC Product Code 35192-039

NDC 35192-039-02

Package Description: 120 g in 1 TUBE

NDC Product Information

Kanjo Pain Relief Gel with NDC 35192-039 is a a human over the counter drug product labeled by Ca-botana International. The generic name of Kanjo Pain Relief Gel is menthol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ca-botana International

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Kanjo Pain Relief Gel 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 6 g/120g

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.

  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • ARNICA MONTANA (UNII: O80TY208ZW)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • HORSE CHESTNUT (UNII: 3C18L6RJAZ)
  • BROMELAINS (UNII: U182GP2CF3)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPSICUM (UNII: 00UK7646FG)
  • TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
  • GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
  • MELISSA OFFICINALIS (UNII: YF70189L0N)
  • DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • WATER (UNII: 059QF0KO0R)
  • ROSEMARY (UNII: IJ67X351P9)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • ALCOHOL (UNII: 3K9958V90M)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.
  • 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: Ca-botana International
Labeler Code: 35192
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: 08-31-2020 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 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.

Kanjo Pain Relief Gel Product Label Images

Kanjo Pain Relief Gel 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

Menthol 5% Topical Analgesic

Other Safety Information

Protect this product from excessive heat and direct sun

Otc - Ask Doctor

Stop use and ask a doctor if redness is present.irritation develops. conditions worsens or symtoms persist more than 7 days. symtoms clear up and occur again within a few days

Otc - Purpose Section

Uses: for temporary relief of minor aches and pains of muscles and joints associated with. simple aches. back aches. arthritis.strains.bruises.sprains.

Keep Out Of Reach Of Children

Keep out of reach of children

Inactive Ingredients

Aesculus hippocastanum (Horse Chestnut), Aloe barbadensis miller, Aloe barbadensis miller (Aloe Vera), Amonium Acrylcydimethyltaurate/VPCcopolymer, Arnica montana (Arnica), Bromelain, Butylene Glycol,
Capsicum annum (Capsicum), Chamaemelum nobile (Chamomile), Ethyl alcohol, Eucalyptus globules (Eucaliptus) oil, FD&C Green # 3, Glucosamine Sulfate, Harpagophytum procumbens (Devil’s Claw), Melissa officinalis (Lemon Balm), Methyl Sulfonyl Methane (MSM), Polysorbate-60, Potassium Sorbate, Purified Water, Rosmarinus officinalis (Rosemary), Salix alba (Willow Bark), Edetic Acid, Tilia cordata (Linden), Xanthan Gum

Warnings

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Dosage & Admnistration

External topical analgesic Topical massage gel no more than 4 times daily

Indications & Usage

Apply generous amount of gel directly affected area massage into painful area until thoroughly absorbed into skin

* Please review the disclaimer below.