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| Product NDC Code | 53329-798 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Isopropyl alcohol |
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| Type | Generic | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | LIQUID | ||||||||||
| RxCUI drug identifier | 797544 | ||||||||||
| Application Number | M003 | ||||||||||
| Labeler Name | Medline Industries, LP | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Isopropyl Alcohol 70%
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 the product on the 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 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 For first aid to help prevent the risk of infection in minor: 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 Alcohol Isopropyl Alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL 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.Package Label Label V1 RE22VJO
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.Manufacturing Information Manufactured for: Medline Industries, LP Three Lakes Drive, Northfield, IL 60093 USA Made in USA with domestic and foreign materials www.medline.com 1-800-MEDLINE (633-5463) REF: MDS098017 V1 RE22VJO
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.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 getting into 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.Ask a doctor before use if you have Deep or puncture wounds, animal bites or serious burns.
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 inhale Do not apply over large ares of the body Do not use longer than 1 week
Storage and handling
Information about safe storage and handling of the drug product.Other Information Does not contain, nor is intended as a substitute for grain or ethyl alcohol. Will produce serious gastric disturbances if taken internally.
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, heat, spark, electrical Ask a doctor before use if you have Deep or puncture wounds, animal bites or serious burns. When using this product do not get into eyes Do not inhale Do not apply over large ares of the body Do not use longer than 1 week Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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 getting into the eyes or on mucous membranes. Avoid inhaling this product
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