NDC 81760-310 Antiseptic Solution

Antiseptic Solution

NDC Product Code 81760-310

NDC 81760-310-01

Package Description: 40 g in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Antiseptic Solution with NDC 81760-310 is a a human prescription drug product labeled by Grupo Salypro De Mexico, S.a. De C.v.. The generic name of Antiseptic Solution is antiseptic solution. The product's dosage form is solution and is administered via topical form.

Labeler Name: Grupo Salypro De Mexico, S.a. De C.v.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription 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.

Antiseptic Solution 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.

  • POTASSIUM PERMANGANATE 5.12 g/100g

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)
  • METHYL ALCOHOL (UNII: Y4S76JWI15)
  • ACETYLSALICYLSALICYLIC ACID (UNII: VBE72MCP5L)
  • .ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)

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: Grupo Salypro De Mexico, S.a. De C.v.
Labeler Code: 81760
Marketing Category: UNAPPROVED DRUG OTHER - 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: 04-01-2021 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".

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Antiseptic Solution Product Label Images

Antiseptic Solution 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

Warning

For external use on the skin only.

Severe injury may result from use internally or as a douche. Avoid contact with mucous membranes."

Indications And Usage

Astringent, Alkaline, for superficial and deep festering wounds. for 1st, 2nd and 3rd ulcers and burns. grade. Ideal for people with diabetes.Úpply directly without diluting, on the affected area or use an impregnated gauze.

Dosage And Administration

It Is Recommended to apply 3 to 5 times a day.

Dosage Forms And Strengths

Antiseptic Solution 40ml

Contraindications

Allergy or hypersensitivity to the active ingredient.

Warnings And Precautions

There may be moderate burning or pain after the first applications of the solution, which usually disappear with the continuation of the treatment.

Drug Interactions

Free drug interactions. No patient presented adverse events related to treatment with Vikút®.

Use In Specific Populations

VIKÚT solution is indicated for pre and post-operative antisepsis and the delimitation of the surgical field. Antisepsis of minor and deep wounds, burns (1, 2, and 3rd degree), lacerations, pyoderma, acne and bacterial and fungal infections of the skin, scalp. In wounds where it is desired to accelerate the healing process such as traumatic surgical wounds, episiotomies, varicose ulcers, decubitus ulcers, where in addition to accelerating the healing process it is desired to eliminate or prevent the presence of pathogenic germs that could delay the process healing.

Label

81760-310-01 40 mL Solution

* Please review the disclaimer below.