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| Product NDC Code | 36800-276 | ||||
|---|---|---|---|---|---|
| Drug Name | Isopropyl alcohol 70 percent |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M003 | ||||
| Labeler Name | TOP CARE (Topco Associates LLC) | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (by volume) Isopropyl Alcohol (70% 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 affected area apply small amount of this product on the area 1-3 times daily if bandaged, let dry first may be covered with a sterile bandage
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient FD&C green #3, FD&C yellow #5, methyl salicylate, 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 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.Isopropyl Alcohol 70 Percent Isopropyl Alcohol ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL WATER FD&C GREEN NO. 3 FD&C YELLOW NO. 5 METHYL SALICYLATE
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 70% Isopropyl Alcohol FIRST AID ANTISEPTIC WITH METHYL SALICYLATE Helps prevent the risk of infection in Minor cuts, Minor scrapes Minor burns WINTERGREEN FL OZ (mL) TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING. DISTRIBUTE BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 Question? 1-888-423-0139 [email protected]
Product Label TOPCARE HEALTH 70% Isopropyl Alcohol Wintergreen Isopropyl alcohol (70% conc.)
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 store at room temperature 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 if you have 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 In case of ingestion, get medical help or contact a Poison Control Center right away.
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 conditions 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 apply over large areas of the body do not use longer than one week unless directed by a doctor
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 use only in a well-ventilated area; fumes may be toxic 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 apply over large areas of the body do not use longer than one week unless directed by a doctor Stop use and ask a doctor if conditions persists or gets worse Keep out of reach of children In case of ingestion, 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