VASHTI by LEADER GREEN CO., LTD. VASHTI- allantoin cream

VASHTI by

Drug Labeling and Warnings

VASHTI by is a Otc medication manufactured, distributed, or labeled by LEADER GREEN CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: PONCIRUS TRIFOLIATA FRUIT, NARINGINASE, LOBELIA SPICATA LEAF, MINERAL OIL, VITAMINE C

Purpose

Purpose: Skin Protectant

WARNINGS

Warnings:
1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children

Indications and usage

Indications and usage:
After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

Dosage and administration

Dosage and administration:
Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VASHTI 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61221-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.25 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
LOBELIA SPICATA LEAF (UNII: 1G4GK01F67)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61221-020-01	50 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/01/2013

Labeler - LEADER GREEN CO., LTD. (688735493)

Registrant - LEADER GREEN CO., LTD. (688735493)

Establishment
Name	Address	ID/FEI	Business Operations
LEADER GREEN CO., LTD.		688735493	manufacture(61221-020)