NDC 30142-979 Kroger Hot And Cold Medicated Patch

Menthol Patch Topical

NDC Product Information

Kroger Hot And Cold Medicated Patch with NDC 30142-979 is a human over the counter drug product labeled by Kroger Company. The generic name of Kroger Hot And Cold Medicated Patch is menthol. The product's dosage form is patch and is administered via topical form.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

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.

Kroger Hot And Cold Medicated Patch 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.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:

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.

  • WATER (UNII: 059QF0KO0R)

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: Kroger Company
Labeler Code: 30142
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: 04-27-2018 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Kroger Hot And Cold Medicated Patch Product Label Images

Kroger Hot And Cold Medicated Patch 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 Ingredient

Active Ingredient ...............................................................................................PurposeMenthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient

Water, Glycerin, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Titanium Dioxide, Kaolin, Tartaric Acid, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben,   PVP

Keep Out Of Reach Of Children

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Temporarily relieves minor aches and pains of muscles and joins associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis■ strains ■ sprains ■ bruises ■ cramps


For External Use Only.

Dosage & Administration

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 4 times daily. Reseal pouch after opening.Children under 12 years of age: Consult a physician.


Topical Analgesic

When Using This Product

Use only as directed ■ Don’t bandage tightly or use with heating pad■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin.

Stop Use And Ask A Doctor

If condition worsens ■ If redness is present ■ If irritation develops■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breastfeeding

Ask a health professional before use.

* Please review the disclaimer below.