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| Product NDC Code | 70000-0332 | ||||
|---|---|---|---|---|---|
| Drug Name | Salicylic acid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 312881 | ||||
| Application Number | M030 | ||||
| Labeler Name | LEADER/ Cardinal Health 110, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid 17%w/w
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 wash affected area and dry thoroughly apply one drop at a time with applicator, to sufficiently cover each corn/callus; let dry use cushions with hole centered over corn or callus to relieve pressure (additional cushions may be purchased separately) repeat this procedure once or twice daily as needed for up to 14 days (until corn/callus is removed)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients camphor, castro oil, ethanol, ethyl ether, nitrocellulose
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 removal of corns and calluses relieves pain by removing corns and calluses
Purpose
Information about the drug product’s indications for use.Purpose Corn and callus remover
Spl product data elements
Usually a list of ingredients in a drug product.Salicylic Acid Liquid Corn and Callus Remover PYROXYLIN CAMPHOR (NATURAL) CASTOR OIL SALICYLIC ACID SALICYLIC ACID
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 LEADER Liquid Corn & Callus Remover Salicylic Acid 17% Safely Removes Corns and Calluses Cushions and Protects 3 Cushions 0.33 FL OZ (9.8 mL) Leader_LCCR_41-030LD-01.jpg
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 on irritated skin on any area that is infected or reddened if you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist
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 between 20 o to 30 o C (68 o to 86 o F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-200-6313
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 avoid inhaling vapors if product gets into the eyes, flush with water for 15 minutes
Safe handling warning
Safe Handling WarningFlammable keep away from fire or flame cap bottle tightly and store at room temperature away heat
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. Flammable keep away from fire or flame cap bottle tightly and store at room temperature away heat Do not use on irritated skin on any area that is infected or reddened if you are a diabetic, or if you have poor blood circulation, except under the advice and supervision of a doctor or podiatrist When using this product avoid contact with eyes avoid inhaling vapors if product gets into the eyes, flush with water for 15 minutes 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