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| Product NDC Code | 0536-1061 | ||||
|---|---|---|---|---|---|
| Drug Name | Rugby ice blue external analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 311502 | ||||
| Application Number | M017 | ||||
| Labeler Name | Rugby Laboratories, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Menthol 2.0%
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: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium hydroxide, blue 1, carbomer, copper sulfate, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water
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 For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains
Purpose
Information about the drug product’s indications for use.Purpose Pain relieving gel
Spl product data elements
Usually a list of ingredients in a drug product.Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM Ammonia FD&C Blue No. 1 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED Cupric Sulfate Isopropyl Alcohol Magnesium Sulfate Anhydrous Sodium Hydroxide Thymol Water
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 PANEL - 226.8 g Jar Label Rugby ® NDC 0536-1061-39 Blue Gel External Analgesic Pain Relieving Gel for Minor Aches and Pains of Muscles and Joints COMPARE TO ACTIVE INGREDIENT IN MINERAL ICE®* NET WT 8 OZ (226.8 g) PRINCIPAL DISPLAY PANEL - 226.8 g Jar 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
Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150
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 other 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 immediately.
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? 1-800-645-2158
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, or if symptoms persist for more than 7 days or clear up and occur again within a few days. redness or 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 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 20 to 25°C (68 to 77°F) Keep lid tightly closed. 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 other 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, or if symptoms persist for more than 7 days or clear up and occur again within a few days. redness or 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 immediately.
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