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| Product NDC Code | 70000-0657 | ||||
|---|---|---|---|---|---|
| Drug Name | Isopropyl alcohol with wintergreen and glycerin |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 808520 | ||||
| Application Number | M003 | ||||
| Labeler Name | Cardinal Health, 110 dba Leader | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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 reaction DIST. BY CAH DUBLIN, OH, 43017 1-800-200-6313 www.myleader.com ©2023 Cardinal Health
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Isopropyl alcohol 70% Purpose First aid antiseptic
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 blue 1, glycerin, methyl salicylate, water, 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.Use 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.Isopropyl Alcohol with Wintergreen and Glycerin Isopropyl Alcohol FD&C BLUE NO. 1 GLYCERIN METHYL SALICYLATE WATER FD&C YELLOW NO. 5 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 LEADER NDC 70000-0657-1 70% Isopropyl Alcohol with Wintergreen & Glycerin First Aid Antiseptic For treatment of minor cuts and scrapes For External Use Only 100% Money Back Guarantee 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 SUIRT WHEN SQUEEZED 16 FL OZ (1 PT) 473 mL MM01
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 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 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.Questions? 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
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.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 Flammable. Keep away from fire or flame, heat, spark, electrical. Ask a doctor before use for deep or puncture wounds, animal bites or serious burns 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 Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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.
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