Lavinna First Sanitizer by MYUNG COSMETIC

Lavinna First Sanitizer by

Drug Labeling and Warnings

Lavinna First Sanitizer by is a Otc medication manufactured, distributed, or labeled by MYUNG COSMETIC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LAVINNA FIRST SANITIZER- alcohol gel 
MYUNG COSMETIC

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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethyl alcohol 70.0 % v/v

INACTIVE INGREDIENT

Inactive ingredients:

Water, Aminomethyl Propanol, Glycerin, Carbomer, Polysorbate 20, Tocopheryl Acetate, Perfume

PURPOSE

Purpose: Antiseptic

WARNINGS

Warnings:

1.Do not use the product on the following areas:
Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)

2.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

3.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.
Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema
Skin irritation symptoms

4.Other precautions
For external use only (do not swallow).
Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.
Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).
If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.
Do not use sealed bandages, cast bandages, or packs as they may cause irritation.
Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.
Use only for the intended purposes.

5.Precautions for storage
Keep away from direct sunlight and do not expose the product to heating devices or flame.
After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.
Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.

Dust or foreign substances may get on the product while using it.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Uses:

Disinfection of hands and skin

Directions

Directions:

Take an appropriate amount on your hands and rub thoroughly to dry.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LAVINNA FIRST SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74777-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
Glycerin (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
Polysorbate 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74777-020-01	100 mL in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2020	04/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2020	04/22/2020

Labeler - MYUNG COSMETIC (688222692)

Registrant - MYUNG COSMETIC (688222692)

Establishment
Name	Address	ID/FEI	Business Operations
MYUNG COSMETIC		688222692	manufacture(74777-020)

Revised: 4/2020

Document Id: fefcfb32-2d41-4327-b26f-4d7818609226

34390-5

Set id: 43570f9d-4758-41a4-935c-cbd5ff857f5a

Version: 2

Effective Time: 20200424

 

MYUNG COSMETIC