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| Product NDC Code | 0869-0211 | ||||
|---|---|---|---|---|---|
| Drug Name | Isopropyl |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 616456 | ||||
| Application Number | M003 | ||||
| Labeler Name | Vi-Jon, LLC | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions Distributed by: Vi-Jon, Inc., 8515 Page Ave., St. Louis, MO 63114
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Isopropyl alcohol 50%
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 the affected area apply a small amount of this product on the affected area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients blue 1, methyl salicylate, 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 first aid to help prevent the risk of infection in: minor cuts scrapes burns
Purpose
Information about the drug product’s indications for use.Purpose First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Isopropyl ISOPROPYL ALCOHOL FD&C BLUE NO. 1 METHYL SALICYLATE WATER D&C YELLOW NO. 10 ISOPROPYL ALCOHOL ISOPROPYL 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.Principal display panel swan ® 50% Isopropyl Alcohol With Wintergreen First Aid Antiseptic For Rubbing & Massaging Square bottle uses less plastic than a similarly sized round bottle. Recyclable (if available in your area) WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame Use only in a well-ventilated area; fumes can be harmful CAUTION: Do not point at self or others; product will squirt when squeezed. 16 FL OZ (1 PT) 473 mL image description
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.Other information does not contain, nor is intended as a substitute for grain or ethyl alcohol
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 for deep or puncture wounds, animal bites or serious burns
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 Caution - Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid gettng in to the eyes or on mucous membranes. Avoid inhaling this product.
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 persists or gets worse
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 get into eyes do not inhal do not apply over large areas of the body do not use longner than 1 week
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. If taken internally serious gastric disturbances will result. Flammable - keep away from fire or flame, heat, spark, electrical
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