VIXA SKINEAL- vixa skineal compound ketoconazole cream

Vixa Skineal by

Drug Labeling and Warnings

Vixa Skineal by is a Prescription medication manufactured, distributed, or labeled by Yunnan Yuyao Bio-pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION:
Apply externally to affected area twice daily. It is suggested to use for 2 weeks on ordinary tinea corporis and tinea cruris, for 4 weeks on tinea pedis and tinea manus.
SIDE EFFECTS:
VIXA SKINEAL has few side effects when used topically. A few instance of irritation or burning sensation may be observed occasionally during the treatment. But usually, it is unnecessary to stop the drug.
CONTRAINDICATION:

PRINCIPAL DISPLAY PANEL

DESCRIPTION:
A white or off-white cream with emulsive base.
PHARMACOLOGICAL ACTIONS:
Ketoconazole is a broad-spectrum anti-fungal agent that acts on the cell membranes of fungi by changing its permeability. Pharmacological studies have shown that Ketoconazole has extremely potent antimycotic actions against dermatophytes (such as Trichophyton sp., Microsporum sp., and epidermophyton sp.), saccharomyces and candida albicans. Strains of fungi are unlikely to have a natural resistance to Ketoconazole. Clobetasol Propionate is cortex hormone that is highly effective as an anti-inflammatory and anti-allergic agent with a few side effects. Neomycin Sulfate is effective against Gram-positive cocci and Gram-negative bacilli. As a result, this compound cream is jointly effective against fungus, bacteria, inflammation and pruritus.
INDICATIONS:
VIXA SKINEAL is indicated for topical application on the treatment of fungal infection of skin, such as tinea manus, tinea pedis, tinea corporis, tinea cruris and tinea versicolor. It is also proved effective on the treatment of many kinds of dermatitis, eczema and pruritus.
DOSAGE AND ADMINISTRATION:
Apply externally to affected area twice daily. It is suggested to use for 2 weeks on ordinary tinea corporis and tinea cruris, for 4 weeks on tinea pedis and tinea manus.
SIDE EFFECTS:
VIXA SKINEAL has few side effects when used topically. A few instance of irritation or burning sensation may be observed occasionally during the treatment. But usually, it is unnecessary to stop the drug.
CONTRAINDICATION:
VIXA SKINEAL is contraindicated in patients with known hypersensitivity to any of its ingredients. It is not for ophthalmic use. Take special precautions when using on pregnancy and infancy.
PRECAUTIONS:
It should be under doctor's supervision to apply VIXA SKINEAL on the face or on large areas for a long period of time.
PACKAGE:
Each tube contains 15g.
STORAGE:
STORE IN A DRY PLACE BELOW 30°C AND AWAY FROM THE SUNLIGHT.
EXPIRATION DATE:
Three years after the manufacturing date.
FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. AVOID CONTACTING EYES.
READ PACKAGE INSERT CAREFULLY BEFORE USING. BATCH NO., MFG. DATE, EXP. DATE ON BOX CAP.
Mfg. by: Yunnan Yuyao Bio-Pharmaceutical Co., Ltd.
Address: High & New Technology Industries Development Zone, Yuxi City, Yunnan Province, P.R.China.

INGREDIENTS AND APPEARANCE

VIXA SKINEAL 
vixa skineal compound ketoconazole cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84659-9040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)	CLOBETASOL PROPIONATE	0.25 mg  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5000 [iU]  in 1 g
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	10 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84659-9040-1	15 g in 1 BOX; Type 0: Not a Combination Product	06/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/01/2024

Labeler - Yunnan Yuyao Bio-pharmaceutical Co.,Ltd. (545993656)

Registrant - Yunnan Yuyao Bio-pharmaceutical Co.,Ltd. (545993656)

Establishment
Name	Address	ID/FEI	Business Operations
Yunnan Yuyao Bio-pharmaceutical Co.,Ltd.		545993656	manufacture(84659-9040)