REVERDIR AMPOULE 7ML- allantoin solution 
AD BIOTECH CO.,LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

REVERDIR AMPOULE 7ML 
allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61098-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.175 mg  in 5 
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Niacinamide (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61098-050-015 in 1 CARTON; Type 0: Not a Combination Product10/01/201412/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201412/30/2020
Labeler - AD BIOTECH CO.,LTD (688713049)
Registrant - AD BIOTECH CO.,LTD (688713049)
Establishment
NameAddressID/FEIBusiness Operations
AD BIOTECH CO.,LTD688713049manufacture(61098-050)

Revised: 6/2021
 
AD BIOTECH CO.,LTD