NDC 59316-994 Iso-quin
Alcohol Gel Topical
NDC Product Code 59316-994
Proprietary Name: Iso-quin 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: 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 antiseptic
NDC Code Structure
- 59316 - Rb Health (us) Llc
- 59316-994 - Iso-quin
NDC 59316-994-20
Package Description: 118 mL in 1 BOTTLE
NDC 59316-994-30
Package Description: 473 mL in 1 BOTTLE
NDC Product Information
Iso-quin with NDC 59316-994 is a human over the counter drug product labeled by Rb Health (us) Llc. The generic name of Iso-quin is alcohol. The product's dosage form is gel and is administered via topical form.
Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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.
Iso-quin 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)
- PEG-15 COCAMINE (UNII: 8L6LB12TSJ)
- CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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: Rb Health (us) Llc
Labeler Code: 59316
FDA Application Number: part333E 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: 05-18-2017 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date: 12-31-2024 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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.
Iso-quin Product Label Images
Iso-quin 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 Ingredients
- Purpose
- Uses:
- Warnings
- When Using This Product
- Directions:
- Keep Out Of Reach Of Children.
- Other Information:
- Inactive Ingredients:
- Questions?
Active Ingredients
Alcohol Denat 68% v/v
Purpose
Antiseptic
Uses:
Helps decrease bacteria on the skin. Recommended for repeated use.
Warnings
For external use only.
When Using This Product
Use in a well-ventilated area. Do not use in or near the eyes. Discontinue use if irritation or redness develop. If condition persists for more than 72 hours consult a doctor. In case of eye contact, flush eyes with water and consult physician.
Directions:
Apply a small amount onto hands and rub briskly until dry. Do not rinse. Children under 6 years of age should be supervised when using this product.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Other Information:
Store in a cool dry place with lid closed tightly
Inactive Ingredients:
Water, PEG-15 Cocamine, Carbomer, Fragrance, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate
Questions?
+1-800 345-2231
* Please review the disclaimer below.