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| Product NDC Code | 58037-702 | ||||
|---|---|---|---|---|---|
| Drug Name | 50% rubbing alcohol first aid antiseptic |
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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 | Pride Products Corp. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Isopropyl alcohol (50% 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 the affected area apply a small amount of product on the affected area 1 to 3 times a day 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.Purified water, methyl salicylate, FD&C Blue #1, FD&C 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, and burns helps relieve minor muscular aches due to exertion
Purpose
Information about the drug product’s indications for use.First aid antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.50% Rubbing Alcohol First Aid Antiseptic Isopropyl Alcohol METHYL SALICYLATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 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.50% 50% ISOPROPYL RUBBING ALCOHOL First Aid Antiseptic For Rubbing & Massaging WINTERGREEN Use only in a well ventilated area; fumes may be harmful. CAUTION: Do not point at self or others; product will squirt when squeezed. WARNING: FLAMMABLE KEEP AWAY FROM HEAT, SPARK, ELECTRICAL, FIRE OR FLAME 12 FL OZ (355 mL) Alcohol's effectiveness at killing germs *drops sharply when diluted below 50% concentration, *and the optimal concentration for killing bacteria is between 60 to 90 percent, according to CDC. For hand sanitization purposes, a 70% dilution is recommended. *This product is intended for massaging, minor cuts and other cleaning purposes. Manufactured for: NEW PRIDE CORP. RONKONKOMA, NY 11779 prideproducts.com A PROUD AMERICAN COMPANY Made in Jordan
50% ISOPROPYL RUBBING ALCOHOL First Aid Antiseptic For Rubbing & Massaging WINTERGREEN Use only in a well ventilated area; fumes may be harmful. CAUTION: Do not point at self or others; product will squirt when squeezed. WARNING: FLAMMABLE KEEP AWAY FROM HEAT, SPARK, ELECTRICAL, FIRE OR FLAME 12 FL OZ (355 mL) Alcohol's effectiveness at killing germs *drops sharply when diluted below 50% concentration, *and the optimal concentration for killing bacteria is between 60 to 90 percent, according to CDC. For hand sanitization purposes, a 70% dilution is recommended. *This product is intended for massaging, minor cuts and other cleaning purposes. Manufactured for: NEW PRIDE CORP. RONKONKOMA, NY 11779 prideproducts.com A PROUD AMERICAN COMPANY Made in Jordan
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Incorrect heading selected
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
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.
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 in the eyes or apply over large areas of the body longer than 1 week do not inhale
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 keep tightly closed at controlled room temperature does not contain, nor is intended as a substitute for grain or ethyl alcohol
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 the condition persists or gets worse irritation, pain, or redness persists or worsens swelling, rash, or fever develops
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 heat, spark, electrical, fire or flame. helps relieve minor muscular aches due to exertion. Do not use in the eyes or apply over large areas of the body longer than 1 week do not inhale Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns. Stop use and ask a doctor if the condition persists or gets worse irritation, pain, or redness persists or worsens swelling, rash, or fever develops Keep out of reach of children. If swallowed 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