Amazon Basics Cold And Hot Medicated Patch
Menthol
Amazon.com Services Llc
Human Otc Drug
NDC 72288-966Amazon Basics Cold And Hot Medicated Patch also known as Menthol is a human otc drug labeled by 'Amazon.com Services Llc'. National Drug Code (NDC) number for Amazon Basics Cold And Hot Medicated Patch is 72288-966. This drug is available in dosage form of Patch. The names of the active, medicinal ingredients in Amazon Basics Cold And Hot Medicated Patch drug includes Menthol - 5 g/100g . The currest status of Amazon Basics Cold And Hot Medicated Patch drug is Active.
Drug Information:
| Drug NDC: | 72288-966 |
| 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: | Amazon Basics Cold And Hot Medicated Patch |
| 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: | Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Amazon.com Services Llc |
| 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: | MENTHOL - 5 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: | 01 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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, 2024 |
| 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: | Amazon.com Services LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 420222
|
| 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: | L7T10EIP3A
|
| 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 |
|---|
| 72288-966-15 | 15 PATCH in 1 CARTON (72288-966-15) / 1 g in 1 PATCH | 01 Jan, 2023 | 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. |
Purpose:
Purpose topical analgesic
Product Elements:
Amazon basics cold and hot medicated patch menthol phenoxyethanol water polyacrylic acid (8000 mw) petrolatum carboxymethylcellulose sodium, unspecified form glycerin sodium polyacrylate (8000 mw) povidone polyethylene glycol 400 iodopropynyl butylcarbamate menthol menthol kaolin polysorbate 80 ethylhexylglycerin dihydroxyaluminum aminoacetate titanium dioxide tartaric acid
Indications and Usage:
Use for temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.
Warnings:
Warnings for external use only when using this product â use only as directed â rare cases of serious burns have been reported with products of this type â don't bandage tightly or use with heating pad â avoid contact with eyes and mucous membranes â don't apply to wounds or damaged skin â do not use at the same time as other topical analgesics. stop use and consult a doctor if â condition worsens â redness is present â irritation develops â symptoms persist for more than 7 days or clear up and occur again within a few days â you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children do not use on infants. if swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using this product â use only as directed â rare cases of serious burns have been reported with products of this type â don't bandage tightly or use with heating pad â avoid contact with eyes and mucous membranes â don't apply to wounds or damaged skin â do not use at the same time as other topical analgesics.
Dosage and Administration:
Directions adults and children 12 years of age and over: carefully remove backing from patch. apply sticky side of patch to affected area. wear one patch up to 8 hours. repeat as necessary, but no more than 3 times daily. discard patch after single use. reseal pouch after opening. children under 12 years of age: consult a physician.
Stop Use:
Stop use and consult a doctor if â condition worsens â redness is present â irritation develops â symptoms persist for more than 7 days or clear up and occur again within a few days â you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
Package Label Principal Display Panel:
Amazon basics cold & hot medicated patch label