NDC 21130-339 Signature Care Cool Heat
Menthol, Methyl Salicylate Cream Topical

Product Information

Signature Care Cool Heat is a human over the counter drug product labeled by Safeway. The generic name of Signature Care Cool Heat is menthol, methyl salicylate. The product's dosage form is cream and is administered via topical form.

Product Code21130-339
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Signature Care Cool Heat
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Menthol, Methyl Salicylate
Product Type 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.
Human Otc Drug
Dosage FormCream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Safeway
Labeler Code21130
FDA Application Number 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.
part348
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-02-2015
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Signature Care Cool Heat?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC 21130-339-21

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC 21130-339-85

Package Description: 1 TUBE in 1 CARTON > 35 g in 1 TUBE

Product Details

What are Signature Care Cool Heat Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Signature Care Cool Heat Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 311500 - menthol 10 % / methyl salicylate 30 % Topical Cream
  • RxCUI: 311500 - menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream

Signature Care Cool Heat Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Signature Care Cool Heat Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredients



Menthol 10%

Methyl salicylate 30%


Purpose



Topical analgesic


Uses



temporarily relieves minor pain associated with

  • •arthritis
  • •simple backache
  • •strains
  • •sprains
  • •bruises

Warnings



For external use only


When Using This Product



  • •use only as directed
  • •do not bandage tightly
  • •do not use with a heating pad
  • •avoid contact with the eyes or mucous membranes
  • •do not apply to wounds or damaged or irritated skin

Stop Use And Ask A Doctor If



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

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions



adults and children over 12 years

  • •apply generously to affected area
  • •massage into painful area until thoroughly absorbed into skin
  • •repeat as necessary, not more than 3 to 4 times daily
  • children 12 years or younger ask a doctor


Other Information



store at 20°-25°C (68°-77°F)


Inactive Ingredients



carbomer homopolymer, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine


Questions Or Comments?



1-888-723-3929


Principal Display Panel



Extra Strength

Cool Heat Cream

COLD & HOT Therapy For Pain

COMPARE TO Icy Hot® Cream active ingredients

Temporary relief of:

Arthritis, back aches, body aches & sore muscles

Extra Strength

Cool Heat Cream

MENTHOL 10%, METHYL SALICYLATE 30%

Pain Relieving Cream

COLD & HOT Therapy For Pain

COMPARE TO Icy Hot® Cream active ingredients

Temporary relief of:

Arthritis, back aches, body aches & sore muscles

NET WT 3 OZ (85 g)


* Please review the disclaimer below.