Pain Relief

Dl-camphor, L-menthol, Methyl Salicylate Patch

Kareway Product, Inc.
Human Otc Drug
NDC 67510-0305

Pain Relief also known as Dl-camphor, L-menthol, Methyl Salicylate Patch is a human otc drug labeled by 'Kareway Product, Inc.'. National Drug Code (NDC) number for Pain Relief is 67510-0305. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Pain Relief drug includes Camphor (synthetic) - .4 mg/1 Levomenthol - 1.8 mg/1 Methyl Salicylate - 2 mg/1 . The currest status of Pain Relief drug is Active.

Drug Information:

Drug NDC:	67510-0305
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:	Pain Relief
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:	Dl-camphor, L-menthol, Methyl Salicylate Patch
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Kareway Product, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Patch
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) - .4 mg/1 LEVOMENTHOL - 1.8 mg/1 METHYL SALICYLATE - 2 mg/1
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:	25 Jan, 2012
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:	Kareway Product, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	853260
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.
UNII:	5TJD82A1ET BZ1R15MTK7 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 NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
67510-0305-2	20 POUCH in 1 CARTON (67510-0305-2) / 1 PATCH in 1 POUCH	25 Jan, 2012	N/A	No
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.

Other medicines with the same generic name

Pain Relief

Dl-camphor, L-menthol, Methyl Salicylate Patch

Patch
Kareway Product, Inc.
NDC: 67510-0305

Purpose:

Purpose topical analgesic topical analgesic topical analgesic

Product Elements:

Pain relief dl-camphor, l-menthol, methyl salicylate patch butylated hydroxytoluene natural latex rubber calcium carbonate sorbitan monostearate alpha-tocopherol acetate zinc oxide camphor (synthetic) camphor (synthetic) levomenthol levomenthol methyl salicylate salicylic acid

Indications and Usage:

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

Warnings:

Warnings for external use only do not use on wounds or damaged skin if you are allergic to aspirin or salicylates with a heating pad with, or at the same time as, other external analgesic products ask a doctor before use, if you are allergic to any ingredients of this product. when using this product use only as directed avoid contact with eyes, mucous membranes or rashes stop use and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

Do Not Use:

When Using:

When using this product use only as directed avoid contact with eyes, mucous membranes or rashes

Dosage and Administration:

Directions adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily for 7 days wear up to 8 hours per application children under 12 years of age: consult a doctor

Stop Use:

Stop use and ask a doctor if rash, itching or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days

Package Label Principal Display Panel:

Carton label pain relief patch image of carton 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.