MedPath

Antiseptic Solution

These highlights do not include all the information needed to use VIKUT safely and effectively. See full prescribing information for www.vikutsolution.com

Approved
Approval ID

bf3eff1d-53ef-2ea0-e053-2995a90a5dca

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 10, 2022

Manufacturers
FDA

Grupo Salypro de Mexico, S.A. de C.V.

DUNS: 951596655

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Antiseptic Solution

PRODUCT DETAILS

NDC Product Code81760-310
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationTOPICAL
Effective DateJanuary 10, 2022
Generic NameAntiseptic Solution

INGREDIENTS (5)

WATERInactive
Quantity: 28.06 g in 100 g
Code: 059QF0KO0R
Classification: IACT
METHYL ALCOHOLInactive
Quantity: 60.75 g in 100 g
Code: Y4S76JWI15
Classification: IACT
POTASSIUM PERMANGANATEActive
Quantity: 5.12 g in 100 g
Code: 00OT1QX5U4
Classification: ACTIB
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOLInactive
Quantity: 4.05 g in 100 g
Code: S8TT5K3C8Y
Classification: IACT
ACETYLSALICYLSALICYLIC ACIDInactive
Quantity: 2.02 g in 100 g
Code: VBE72MCP5L
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/1/2021

LABEL

81760-310-01 40 mL Solution 40 mL Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/1/2021

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.

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 4/1/2021

CONTRAINDICATIONS

Allergy or hypersensitivity to the active ingredient.

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 4/1/2021

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 SECTION

LOINC: 34073-7Updated: 4/1/2021

DRUG INTERACTIONS

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

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2021

WARNING

For external use on the skin only.
Severe injury may result from use internally or as a douche. Avoid contact with mucous membranes."

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2021

DOSAGE AND ADMINISTRATION

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

DOSAGE FORMS & STRENGTHS SECTION

LOINC: 43678-2Updated: 4/1/2021

DOSAGE FORMS AND STRENGTHS

Antiseptic Solution 40ml

USE IN SPECIFIC POPULATIONS SECTION

LOINC: 43684-0Updated: 4/1/2021

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.

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 4/5/2021

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Antiseptic Solution - FDA Drug Approval Details