REVERDIR AMPOULE 7ML- allantoin solution

REVERDIR AMPOULE 7mL by

Drug Labeling and Warnings

REVERDIR AMPOULE 7mL by is a Otc medication manufactured, distributed, or labeled by AD BIOTECH CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Sodium Hyaluronate, Niacinamide, 1,2-Hexanediol, Betaine, Trehalose, Cavasol, Portulaca Oleracea Extract, Centella Asiatica Extract, Poncirus Trifoliata Fruit Extract, Butylene Glycol, Allantoin, Bis-PEG-18 Methyl Ether Dimethyl Silane, Cellulose Gum, Hydroxyethylcellulose, Adenosine, Disodium EDTA, Oligopeptide-91 rh-Oligopeptide-1(and) Sodium Carbonate(and) Trehalose, Trehalose (and) rh-Polypeptide-11 Dipeptide-19 Oligopeptide-91 Hexapeptide-40)

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning:
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 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 & USAGE

Indication & Usage:
STEP 1 When pressed the button that contains the ampoule powder, the stopper is opened and powder will come down to a solution.
STEP 2 Shake it 5-6 times to mix the powder and solution, stop after 1-2 minutes.
STEP 3 Replace with the built-in spoid by opening the stopper of the powder.
STEP 4 Close well after using the moderate amount of ampoule with a spoid.

DOSAGE & ADMINISTRATION

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REVERDIR AMPOULE 7ML 
allantoin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61098-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.175 mg  in 5

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Niacinamide (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61098-050-01	5 in 1 CARTON; Type 0: Not a Combination Product	10/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2014

Labeler - AD BIOTECH CO.,LTD (688713049)

Registrant - AD BIOTECH CO.,LTD (688713049)

Establishment
Name	Address	ID/FEI	Business Operations
AD BIOTECH CO.,LTD		688713049	manufacture(61098-050)