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| Product NDC Code | 69452-375 | ||||
|---|---|---|---|---|---|
| Drug Name | Cool and heat pain relieving liquid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part348 | ||||
| Labeler Name | Bionpharma 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 16%
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 yrs of age : apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER Children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, Purified Water, SD Alcohol 40 (30%), Triethanolamine
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 muscle and joint pain associated with arthritis simple backache muscle strains sprains 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.cool and heat pain relieving liquid Menthol CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) PROPYLENE GLYCOL TROLAMINE ALCOHOL CAPSAICIN ISOPROPYL MYRISTATE GLYCERIN WATER 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.Carton *compare to the active ingredient in Icy Hot® a+health™ maximum strength cool & heat pain relieving liquid menthol 16% topical analgesic rool-on applicator no mess dries rapidly stain-free 2.5 fl oz (74mL) carton
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.*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Icy Hot®. actual size package containes one bottle DISTRIBUTED BY: Bionpharma Inc., Princeton, NJ 08540 L0000588 R03/22
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions & comments? call toll free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
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 redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days
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.For external use only. When using this product: use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately If swelling or blistering of the skin occurs, stop use and seek medical attention Do not expose treated area to heat or direct sunlight.
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 or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately If swelling or blistering of the skin occurs, stop use and seek medical attention Do not expose treated area to heat or direct sunlight. Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days Flammable Keep away from fire or flame Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding , ask a health professional before use.
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