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| Product NDC Code | 69103-5500 | ||||
|---|---|---|---|---|---|
| Drug Name | Isopropyl alcohol |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SPRAY | ||||
| RxCUI drug identifier | 1014638 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Provision Medical | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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 spray over cleaned affected area 1 to 3 times daily
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients purified 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 First aid to help prevent 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.Isopropyl 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.Principal Display Panel – 2 fl. oz Bottle Label The Provision First Aid Line™ Isopropyl Alcohol Spray First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns. 2 fl. oz. (59.1 ml) Reorder no. 3502 Principal Display Panel – 2 fl. oz Bottle Label
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 near eyes or mucous membranes on 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 Caution not for use on large areas of the body if redness, irritation, swelling or pain persists or increases, discontinue use 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. Do not use near eyes or mucous membranes on deep or puncture wounds, animal bites or serious burns Keep out of reach of children Caution not for use on large areas of the body if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician.
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