Katinko Pain And Itch Relieving

Camphor (synthetic), Menthol, Methyl Salicylate


Greenstone Pharmaceutical Inc.
Human Otc Drug
NDC 52241-100
Katinko Pain And Itch Relieving also known as Camphor (synthetic), Menthol, Methyl Salicylate is a human otc drug labeled by 'Greenstone Pharmaceutical Inc.'. National Drug Code (NDC) number for Katinko Pain And Itch Relieving is 52241-100. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Katinko Pain And Itch Relieving drug includes Camphor (synthetic) - 11 g/100g Menthol - 7.6 g/100g Methyl Salicylate - 13 g/100g . The currest status of Katinko Pain And Itch Relieving drug is Active.

Drug Information:

Drug NDC: 52241-100
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Katinko Pain And Itch Relieving
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Camphor (synthetic), Menthol, Methyl Salicylate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Greenstone Pharmaceutical Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CAMPHOR (SYNTHETIC) - 11 g/100g
MENTHOL - 7.6 g/100g
METHYL SALICYLATE - 13 g/100g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: OTC MONOGRAPH NOT FINAL
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 24 May, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 10 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: part348
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Greenstone Pharmaceutical Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1542816
1542818
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0852241018029
0852241018012
UPC stands for Universal Product Code.
UNII:5TJD82A1ET
L7T10EIP3A
LAV5U5022Y
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
52241-100-031 JAR in 1 CARTON (52241-100-03) / 3 g in 1 JAR24 May, 2010N/ANo
52241-100-101 JAR in 1 CARTON (52241-100-10) / 10 g in 1 JAR24 May, 2010N/ANo
52241-100-301 BOTTLE in 1 CARTON (52241-100-30) / 30 g in 1 BOTTLE24 May, 2010N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose topical analgesic topical analgesic topical analgesic

Product Elements:

Katinko pain and itch relieving camphor (synthetic), menthol, methyl salicylate petrolatum paraffin eucalyptus oil camphor (synthetic) camphor (synthetic) menthol menthol methyl salicylate salicylic acid

Indications and Usage:

Uses: for temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis rheumatism muscle strain sprains bruises for temporary relief of pain and itching associated with: insect bites minor skin irritation

Warnings:

Warnings for external use only.

When Using:

When using this product: use only as directed. do not apply to wounds or damaged skin. do not use on the eyes or on the mucous membranes. do not use with a heating pad or apply external heat.

Dosage and Administration:

Directions: adults and children 2 yrs and up apply to affected areas not more than 3 to 4 times daily children under 2 years consult a doctor before use

Stop Use:

Stop use and ask a doctor if: skin redness or excessive irritation of the skin occurs condition worsens symptoms persists for more than 7 days or clears up and occurs again within a few days do not bandage tightly

Adverse Reactions:

Other information this product make provoke allergic reaction in some individuals. test on small area before use.

Package Label Principal Display Panel:

10g stickers 10g box

30g package label 30g label


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.