ANTISEPTIC SOLUTION- antiseptic solution solution 
Grupo Salypro de Mexico, S.A. de C.V.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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 40 mL Label

ANTISEPTIC SOLUTION 
antiseptic solution solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81760-310
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM PERMANGANATE (UNII: 00OT1QX5U4) (PERMANGANATE ION - UNII:2BL953CCZ2) POTASSIUM PERMANGANATE5.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 28.06 g  in 100 g
METHYL ALCOHOL (UNII: Y4S76JWI15) 60.75 g  in 100 g
ACETYLSALICYLSALICYLIC ACID (UNII: VBE72MCP5L) 2.02 g  in 100 g
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y) 4.05 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81760-310-0140 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2021
Labeler - Grupo Salypro de Mexico, S.A. de C.V. (951596655)
Establishment
NameAddressID/FEIBusiness Operations
Grupo Salypro de Mexico, S.A. de C.V.951596655manufacture(81760-310)

Revised: 1/2022
Document Id: d5483a8e-e04b-b371-e053-2a95a90aaf6a
Set id: bf3eff1d-53ef-2ea0-e053-2995a90a5dca
Version: 5
Effective Time: 20220110
 
Grupo Salypro de Mexico, S.A. de C.V.