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| Product NDC Code | 69822-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Icequake coldn hot medicated |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | part348 | ||||
| Labeler Name | Southern Sales & Service, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Adults and children over 12 years Carefully remove backing film from patch Apply one patch to affected area Use one patch at a time, 1 or 2 times a day Children under 12 years of age Consult a physician
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients aluminum glycinate, castor oil, concentrate glycerin, disodium edetate hydrate, gelatin, glycol salicylate, isopropyl myristate, mentha oil, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tataric acid, titanium oxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relieves minor pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle srains bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.IceQuake Coldn Hot Medicated Menthol DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS CASTOR OIL GLYCERIN EDETATE DISODIUM GELATIN, UNSPECIFIED GLYCOL SALICYLATE ISOPROPYL MYRISTATE POLYSORBATE 80 POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE WATER SODIUM POLYACRYLATE (2500000 MW) TARTARIC ACID TITANIUM DIOXIDE MENTHOL MENTHOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.IceQuake Coldn Hot Medicated Patch 69822-010-04 Bottle label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts Active Ingredient Menthol 5% Purpose Topical Analgesic Uses Temporarily relieves minor pain associated with: arthritis muscle strains simple backache bursitis cramps tendonitis muscle srains bruises Warnings For external use only 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 do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product 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 If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away Directions Adults and children over 12 years Carefully remove backing film from patch Apply one patch to affected area Use one patch at a time, 1 or 2 times a day Children under 12 years of age Consult a physician Other information store at room temperature Inactive Ingredients aluminum glycinate, castor oil, concentrate glycerin, disodium edetate hydrate, gelatin, glycol salicylate, isopropyl myristate, mentha oil, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tataric acid, titanium oxide
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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 do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only 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 do not apply to wounds or damaged skin do not use if you are allergic to any ingredients of this product 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 If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API