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| Product NDC Code | 30400-601 | ||||
|---|---|---|---|---|---|
| Drug Name | 91% isopropyl rubbing alcohol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 582901 | ||||
| Application Number | part333A | ||||
| Labeler Name | Jell Pharmaceuticals Pvt Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (by volume): Isopropyl alcohol (91% conc.)
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 effected area • Apply small amount of this product on the area 1-3 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 Ingredient Water(Aqua)
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 and 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.91% Isopropyl Rubbing Alcohol Isopropyl alcohol WATER 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.Packaging Label
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
AS 9175 Use only in a well ventilated area Fumes may be harmful WARNING FLAMMABLE keep away from fire or flame! 91% by volume TAMPER EVIDENT: DO NOT USE IF THE UNDER CAP SAFETY FOIL IS BROKEN OR MISSING Made in India DISTRIBUTED: JMD ALLSTAR IMPEX INC 120 ETHEL ROAD, PISCATAWAY, NJ 08854, USA DESIGNED IN THE USA
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 this drug out of the reach of children • In case of an accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately
Storage and handling
Information about safe storage and handling of the drug product.Other information • Store at room temperature • 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, etc. Ask a doctor before use if you have • Deep punctured wounds, animal bites or serious burns When using this product • Do not get into eyes • Do not apply over large areas of the body • Do not use longer than one week unless directed by a doctor Stop using this product if • Condition persists or gets worse Keep this drug out of the reach of children • In case of an accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1222) immediately
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