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| Product NDC Code | 70000-0020 | ||||
|---|---|---|---|---|---|
| Drug Name | Ethyl rubbing alcohol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 582753 | ||||
| Application Number | part333A | ||||
| Labeler Name | Cardinal Health, 110 dba Leader | ||||
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse event DSP-TN-21091 DSP-MO-20087 DIST. BY CAH DUBLIN, OH 43017 www.myleader.com 1-800-200-6313 © 2023 Cardinal Health. CIN 5516059 REV. 5/23
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl 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 this 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 acetone, denatonium benzoate, methyl isobutyl ketone, 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 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.Ethyl Rubbing Alcohol Ethyl alcohol ALCOHOL ALCOHOL ACETONE DENATONIUM BENZOATE METHYL ISOBUTYL KETONE 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.Principal Panel Display LEADER NDC 70000-0020-1 Ethyl Rubbing Alcohol 70% by Volume Fisrt Aid Antiseptic For Rubbing and Massaging 100% Money Back Guarantee 16 FL OZ (1 PT) 473 mL WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame USE ONLY IN A WELL-VENTILATED AREA; FUMES CAN BE HARMFUL. CAUTION: DO NOT POINT AT SELF OR OTHERS; PRODUCT WILL SQUIRT WHEN SQUEEZED. image description
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 for 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. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Quesstions or comments? 1-888-593-0593
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 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 areas of the body do not use longer than 1 week
Precautions
Information about any special care to be exercised for safe and effective use of the drug.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.
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, heat spark, electrical
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