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Product NDC Code | 59316-997 | ||||||||
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Drug Name | Iso-quin |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LIQUID | ||||||||
RxCUI drug identifier | 884783 | ||||||||
Application Number | part333E | ||||||||
Labeler Name | Performance Health, LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Alcohol Denat 65% v/v Purpose Antiseptic
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: Apply a small amount onto hands and rub briskly until dry. Do not rinse. Children under 6 years of age should be supervised when using this product.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Water, Isopropyl Alcohol, Fragrance, Yellow #11
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: Helps decrease bacteria on the skin. Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Iso-Quin ALCOHOL WATER ISOPROPYL ALCOHOL D&C YELLOW NO. 11 ALCOHOL ALCOHOL
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.59316-997-20 Bottle14
59316-997-30 Bottle15
59316-997-50 Bottle16
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
Other Information: Store in a cool dry place with lid closed tightly
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? +1800 345-2231
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 in a well-ventilated area. Do use in or near the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. In case of eye contact, flush eyes with water and consult a physician.
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. When using this product Use in a well-ventilated area. Do use in or near the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. In case of eye contact, flush eyes with water and consult a physician. 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