Icy Freeze
Menthol, Unspecified Form
Natural Essentials, Inc.
Human Otc Drug
NDC 66902-168Icy Freeze also known as Menthol, Unspecified Form is a human otc drug labeled by 'Natural Essentials, Inc.'. National Drug Code (NDC) number for Icy Freeze is 66902-168. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Icy Freeze drug includes Menthol, Unspecified Form - 89 mg/mL . The currest status of Icy Freeze drug is Active.
Drug Information:
| Drug NDC: | 66902-168 |
| 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: | Icy Freeze |
| 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, Unspecified Form |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natural Essentials, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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, UNSPECIFIED FORM - 89 mg/mL
|
| 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: | 14 May, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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, 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: | Natural Essentials, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 66902-168-40 | 120 mL in 1 CAN (66902-168-40) | 14 May, 2020 | 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 cooling pain relief
Product Elements:
Icy freeze menthol, unspecified form menthol, unspecified form menthol, unspecified form aloe vera leaf ilex paraguariensis leaf camphor (synthetic) alcohol .alpha.-tocopherol acetate water
Indications and Usage:
Uses temporary relief from minor aches and pains associated with: tendonitis strains sprains sore muscles joint discomfort arthritis
Warnings:
Warnings for external use only flammable keep away from excessive heat or open flame do not use with heating pad or device with creams, ointments, sprays or liniments on wounds damaged skin or irritated skin ask a doctor before use if you have sensitive skin are pregnant or breastfeeding when using this product avoid contact with eyes or mucous membranes do not bandage tightly stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up then reoccur again within a few days irritation develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only flammable keep away from excessive heat or open flame do not use with heating pad or device with creams, ointments, sprays or liniments on wounds damaged skin or irritated skin ask a doctor before use if you have sensitive skin are pregnant or breastfeeding when using this product avoid contact with eyes or mucous membranes do not bandage tightly stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up then reoccur again within a few days irritation develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product avoid contact with eyes or mucous membranes do not bandage tightly
Dosage and Administration:
Directions adults/children 2 years and older apply to the affected area not more than 3 to 4 times daily; rub into skin until solution vanishes children under 2 years old: application should be supervised by an adult.
Stop Use:
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up then reoccur again within a few days irritation develops keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Principal display panel 4 oz can label therapeutic pain relief greaseless and stain free with aloe, vitamin e and ilex natural ingredients soothing menthol vanishing scent icy freeze cooling pain relief for tendonitis, arthritis. sprains and strains freezes pain 360° continuous spray 4 fl oz (120 ml) figure
Further Questions:
Questions? call 317-689-7711