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| Product NDC Code | 70000-0617 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader roll-on cooling pain relief topical analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 415974 | ||||
| Application Number | M017 | ||||
| Labeler Name | Cardinal Health, 110 dba LEADER | ||||
| 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 4%
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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily ⬥ Children under 2 years of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe barbadensis leaf juice, arnica montana flower extract, blue 1, boswellia serrata resin extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, isopropyl alcohol, isopropyl myristate, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5.
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, and sprains
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.Leader Roll-On Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALOE VERA LEAF Arnica Montana Flower FD&C BLUE NO. 1 INDIAN FRANKINCENSE Calendula Officinalis Flower GREEN TEA LEAF CAMPHOR (SYNTHETIC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE Glycerin Isopropyl Alcohol Isopropyl Myristate SILICON DIOXIDE Sodium Hydroxide .ALPHA.-TOCOPHEROL ACETATE, DL- Water FD&C YELLOW NO. 5
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 - 74 mL Bottle Label LEADER ™ NDC 70000-0617-1 Roll-On Cooling Pain Relief Gel Menthol, 4% | Topical Analgesic Pain Relieving Gel For Arthritis Back Pain Sore Muscles & Joints Hands-Free Roll-On Applicator Paraben-Free COMPARE TO BIOFREEZE ® active ingredient* 100% Money Back Guarantee 2.5 FL OZ (74 mL) PRINCIPAL DISPLAY PANEL - 74 mL 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
DIST. BY CAH DUBLIN, OH 43017
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have sensitive skin
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 Poison Control Center (1-800-222-1222) 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? 1-866-567-8600
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 consult a doctor if condition worsens, or if 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.When using this product ⬥ Avoid contact with eyes ⬥ Do not apply to wounds or damaged skin ⬥ Do not use with other ointments, creams, sprays or liniments ⬥ Do not apply to irritated skin or if excessive irritation develops ⬥ Do not bandage tightly ⬥ Wash hands after use with cool water ⬥ Do not use with heating pads or heating devices
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 in a cool dry place with lid closed tightly.
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 Ask a doctor before use if you have sensitive skin When using this product ⬥ Avoid contact with eyes ⬥ Do not apply to wounds or damaged skin ⬥ Do not use with other ointments, creams, sprays or liniments ⬥ Do not apply to irritated skin or if excessive irritation develops ⬥ Do not bandage tightly ⬥ Wash hands after use with cool water ⬥ Do not use with heating pads or heating devices Stop use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days. Flammable ⬥ keep away from excessive heat or open flame If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) 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