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| Product NDC Code | 0316-0226 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Mineral ice pain relieving |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | GEL | ||||||||
| RxCUI drug identifier | 311502, 692869 |
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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 2%
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 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 ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol
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 Pain Relieving Menthol AMMONIA CARBOMER HOMOPOLYMER TYPE B CUPRIC SULFATE FD&C BLUE NO. 1 ISOPROPYL ALCOHOL MAGNESIUM SULFATE HEPTAHYDRATE SODIUM HYDROXIDE THYMOL 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.Principal Display NDC 0316-0226-08 ORIGINAL THERAPEUTIC Mineral Ice® Menthol Pain Relieving Gel Greaseless with DEEPCOLD® Pain Reliever Net wt. 8 oz (226.8 g) P11529.00 p1152900
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 1-833-279-6522 ©Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604 ©2018 Made in Canada. Mineral Ice and the Mineral Ice mountain range are registered trademarks of Crown Laboratories, Inc.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.If pregnant or breast-feeding, ask a health professional before use.
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature], in a tightly closed container store in a cool place do not use, pour, spill or store near heat or open flame
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 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