NDC 36800-071 Isopropyl Alcohol 50 Percent
Liquid Topical
NDC Product Code 36800-071
Proprietary Name: Isopropyl Alcohol 50 Percent What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: Isopropyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used as first aid antiseptic
NDC Code Structure
- 36800 - Top Care (topco Associates Llc)
- 36800-071 - Isopropyl Alcohol
NDC 36800-071-16
Package Description: 473 mL in 1 BOTTLE, PLASTIC
NDC 36800-071-25
Package Description: 71 g in 1 BOTTLE, PLASTIC
NDC Product Information
Isopropyl Alcohol 50 Percent with NDC 36800-071 is a human over the counter drug product labeled by Top Care (topco Associates Llc). The product's dosage form is liquid and is administered via topical form.
Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Isopropyl Alcohol 50 Percent Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
RxNorm Crosswalk
What is RxNorm?RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.
The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:
Inactive Ingredient(s)
About the Inactive Ingredient(s)The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
- WATER (UNII: 059QF0KO0R)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Top Care (topco Associates Llc)
Labeler Code: 36800
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 10-31-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
* Please review the disclaimer below.
Information for Patients
Miconazole
Miconazole is pronounced as (mi kon' a zole)
Why is miconazole medication prescribed?
Miconazole, an antifungal agent, is used for skin infections such as athlete's foot and jock itch and for vaginal yeast infections.This medication is sometimes prescribed...
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* Please review the disclaimer below.
Isopropyl Alcohol 50 Percent Product Label Images
Isopropyl Alcohol 50 Percent Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
- Active Ingredient (By Volume)
- Purpose
- Uses
- Warnings
- Ask A Doctor Before Use If You Have
- When Using This Product
- Stop Use And Ask A Doctor If
- Keep Out Of Reach Of Children.
- Directions
- Other Information
- Inactive Ingredient
- Package Label
Active Ingredient (By Volume)
Isopropyl alcohol (50% conc.)
Purpose
First aid antiseptic
Uses
- First aid to help prevent the risk of infection in minor cuts, scrapes and burns
Warnings
- For external use onlyflammable, keep away from fire or flameif taken internally serious gastric disturbances will result
Ask A Doctor Before Use If You Have
- Deep or puncture woods, animal bites or serious burns
When Using This Product
- Do not get into eyesdo not apply over large areas of the bodydo not use longer than one week unless directed by a doctor
Stop Use And Ask A Doctor If
- Condition persists or gets worse
Keep Out Of Reach Of Children.
In case of ingestion, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Directions
- Clean affected areaapply small amount of this product on the area 1-3 times dailyif bandaged, let dry firstmay be covered with a sterile bandage
Other Information
- Store at room temperaturedoes not contain, nor is intended as a substitute for grain or ethyl alcohol
Inactive Ingredient
Purified water
Package Label
TopCare 50% Isopropyl Alcohol
* Please review the disclaimer below.