NDC 69822-010 Icequake Cold Hot

Menthol

NDC Product Code 69822-010

NDC 69822-010-04

Package Description: 4 PATCH in 1 BOX > 9 g in 1 PATCH

NDC Product Information

Icequake Cold Hot with NDC 69822-010 is a a human over the counter drug product labeled by Southern Sales & Service, Inc.. The generic name of Icequake Cold Hot is menthol. The product's dosage form is patch and is administered via topical form.

Labeler Name: Southern Sales & Service, Inc.

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.

Icequake Cold Hot 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.

  • MENTHOL 5 g/100g

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.

  • DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIETHYLENE GLYCOL (UNII: 61BR964293)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • TARTARIC ACID (UNII: W4888I119H)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Southern Sales & Service, Inc.
Labeler Code: 69822
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: 03-01-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Icequake Cold Hot Product Label Images

Icequake Cold Hot 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

Warnings

For External Use Only.

Active Ingredient

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

Inactive Ingredient

Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide

Indications & Usage

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis
■ muscle strains ■ muscle sprains ■ bruises ■ cramps

Dosage & Administration

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply one patch to affected areaRepeat as necessary, but no more than 4 times daily. Children under 12 years of age: Ask a doctor.

Purpose

Topical Analgesic

When Using This Product

Use only as directed ■ Do not bandage tightly.■ Do not use a heating pad.■ Avoid contact with eyes and mucous membranes. ■ Don’t apply to wounds or damaged skin.■ Do not use if you are alergic to any ingredients of this product.

Stop Use And Ask A Doctor

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

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breastfeeding

Ask a health professional before use.

* Please review the disclaimer below.

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