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| Product NDC Code | 0316-0290 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral ice quick dry foam |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | AEROSOL, FOAM | ||||
| RxCUI drug identifier | 2550732, 2550735 |
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| Application Number | M017 | ||||
| Labeler Name | Crown Laboratories | ||||
| 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 10%
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 ● clean affected area before applying product ● hold can at an angle and press nozzle lightly ● dispense onto hand and then apply to target area ● wipe nozzle clean after each use ● replace the overcap after each use ● adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ● children under 2 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aluminum Starch Octenylsuccinate, Caprylyl Glycol, Cetyl Alcohol, Cocamidopropyl Betaine, Ethanol, Isobutane, Phenoxyethanol, Purified Water, Sodium Chloride, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer
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 aches and pains of muscles and joints associated with: ● arthritis ● simple backache ● strains ● bruises ● sprains ● provides cooling penetrating relief
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.Mineral Ice Quick Dry Foam Menthol ALCOHOL PHENOXYETHANOL 2-(DIBUTYLAMINO)ETHYL METHACRYLATE CAPRYLYL GLYCOL CETYL ALCOHOL COCAMIDOPROPYL BETAINE ISOBUTANE WATER N-VINYLCAPROLACTAM N-VINYLPYRROLIDINONE MENTHOL MENTHOL ALUMINUM STARCH OCTENYLSUCCINATE SODIUM CHLORIDE
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.Mineral Ice Quick Dry Foam - 4 oz Canister Label NDC 0316-0290-04 NEW ORIGINAL THERAPEUTIC Mineral Ice QUICK DRY FOAM MENTHOL PAIN RELIEVING FOAM MAXIMUM STRENGTH Greaseless with DEEPCOLD Pain Reliever Net wt. 4 oz (113 g) mineralicefoam
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Formatted Uses section Formatted Directions section
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.Additional Information Listed on Other Panels ©2020 Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 Made in USA P11842.00 DOT 2Q M5706
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ● with other topical pain relievers ● with heating pads or heating devices
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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] ● do not store at temperatures above 50°C
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-833-279-6522
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 last 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.When using this product ● do not use in or near the eyes ● do not apply to wounds or damaged skin ● do not bandage tightly
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 Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes. Do not use ● with other topical pain relievers ● with heating pads or heating devices When using this product ● do not use in or near the eyes ● do not apply to wounds or damaged skin ● do not bandage tightly Stop use and ask a doctor if • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days 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