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| Product NDC Code | 70000-0169 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader maximum strength pain relieving analgesic |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 313518 | ||||
| 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 ingredients Trolamine Salicylate
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 12 years of age and older: apply to affected area not more than 4 times per day. Massage into painful area until thoroughly absorbed into skin ♦ children under 12 years of age: do not use, consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Extract, Cetyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Potassium Phosphate, Propylparaben, Sodium Hydroxide, Stearic Acid, 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 temporarily relieves minor pain associated with: ♦ arthritis ♦ simple backache ♦ muscle strains ♦ sprains ♦ bruises ♦ cramps
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 Maximum Strength Pain Relieving Analgesic Trolamine Salicylate Trolamine Salicylate SALICYLIC ACID Aloe Vera Leaf Cetyl Alcohol Glycerin Methylparaben Mineral Oil Potassium Phosphate, Unspecified Form Propylparaben Sodium Hydroxide Stearic Acid 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 - 85 g Tube Carton MAXIMUM STRENGTH NDC 70000-0169-1 Pain Relieving Cream Trolamine Salicylate, 10% Topical Analgesic Rub Temporary Relief of Minor Muscle Aches and Pains Associated with Arthritis, Simple Backache or Sprains Fast Acting • Odor Free • With Aloe COMPARE TO ASPERCREME ® MAXIMUM STRENGTH active ingredients* 100% Money Back Guarantee NET WT 3 OZ (85 g) PRINCIPAL DISPLAY PANEL - 85 g Tube 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.Drug Facts
DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 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.Allergy alert! If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
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 at 1-800-222-1222.
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 symptoms persist for more than 7 days or clear up and occur again within a few days ♦ redness is present ♦ 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 ♦ use only as directed. Read an follow all directions and warnings on this label ♦ do not bandage tightly or apply local heat (such as heating pads) to the area of use ♦ avoid contact with eyes and mucous membranes ♦ do not apply to wounds or damaged, broken or irritated skin ♦ do not use at the same time as other topical analgesics
Pregnancy or breast feeding
Pregnancy or Breast feedingIf you are pregnant or nursing a baby , seek the advice of a health professional before using this product.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature
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 Allergy alert! If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. When using this product ♦ use only as directed. Read an follow all directions and warnings on this label ♦ do not bandage tightly or apply local heat (such as heating pads) to the area of use ♦ avoid contact with eyes and mucous membranes ♦ do not apply to wounds or damaged, broken or irritated skin ♦ do not use at the same time as other topical analgesics Stop use and consult a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days ♦ redness is present ♦ irritation develops If you are pregnant or nursing a baby , seek the advice of a health professional before using this product. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.
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