NDC 77922-0625 Bay Rum Valle Verde

Alcohol 40%

NDC Product Code 77922-0625

NDC 77922-0625-1

Package Description: 24 BOTTLE, PLASTIC in 1 BOX > 355 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Bay Rum Valle Verde with NDC 77922-0625 is a a human over the counter drug product labeled by Vialen Srl. The generic name of Bay Rum Valle Verde is alcohol 40%. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Vialen Srl

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.

Bay Rum Valle Verde 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.

  • ALCOHOL 40 mL/100mL

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.
  • 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: Vialen Srl
Labeler Code: 77922
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: 08-24-2020 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: 12-31-2021 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Bay Rum Valle Verde Product Label Images

Bay Rum Valle Verde 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(S)

Alcohol 40% Purpose: First Aid Antiseptic

Purpose

First Aid Antiseptic, Refreshing Aromatic Stimulant

Indications & Usage

First Aid to help prevent infections in minor cuts, scrapes and burnsAromatic Stimulant. It offers a sensation of freshness. Reanimates in case of tiredness or dizziness.

Warnings

  • For external use only. Flammable, keep away from fire or flameDo not useIn the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns consult a Doctor.Longer than 1 week, unless ddirected by a doctor.

Otc - Stop Use

Stop use and ask a doctor if the condition persist or gets worse.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask the health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of overdose, get Medical help or contact a Poison Control Center right away.

Directions

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily.

Other Information

Store at controlled room temperature: 15-30 C (59-86 F).Tamper Evident Feature: Do not use if the headband of the cap has been violated.

Inactive Ingredients

Water, Bay Rum fragrance.

* Please review the disclaimer below.