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Product NDC Code | 68356-117 | ||||
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Drug Name | Isopropyl alcohol |
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Type | Generic | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SWAB | ||||
RxCUI drug identifier | 797544 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | LernaPharm Loris Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each swab) Isopropyl Alcohol 70% v/v
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 Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward.
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 For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.
Purpose
Information about the drug product’s indications for use.Purpose 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 NDC 68356-117-02 PRODUCT # 117-02U LORIS - ALCOHOL SWABS MEDIUM Saturated with 70% v/v isopropyl alcohol, USP Single use only ● For external use only ● Easy to use ● Economical Antiseptic Non-Sterile Solution and Swab 200 units image of outer box packaging image of individual swab package
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 or comments? Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store at room temperature between 59 - 86 0 F (15 - 30 0 C)
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 Flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. 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