AAPE SKIN AMPOULE- allantoin solution 
PROSTEMICS 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
Ampoule I: Human Adipocyte Conditioned Media Extract, Mannitol
Ampoule II: Water, Butylene Glycol, Niacinamide, Glycerin, 1,2-Hexanediol, Palmitoyl Tripeptide-5, Sorbitol, Acetyl Hexapeptide-8, rh-Oligopeptide-1, Hydrolyzed Collagen, Sodium Hyaluronate, Portulaca Oleracea Extract, Xanthan Gum, Origanum Majorana Leaf Extract,
Paeonia Suffruticosa Root Extract, Perilla Ocymoides Leaf Extract, Hypericum Perforatum Flower/Leaf/Stem Extract, Gossypium Herbaceum (Cotton) Seed Extract, Magnolia Kobus Bark Extract, Lilium Tigrinum Extract, Nelumbo Nucifera Flower Extract, Paeonia Albiflora Root Extract,
Adenosine, Disodium EDTA

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warning:
1. In case of having following symptoms after using this product, stop using it immediately. If the symptoms get worse, you need to consult a dermatologist.
1) In case of having problems such as red spots, swelling, itching or irritation during using this product
2) In case of having the same symptoms above on the part where you put this product, which is exposed to direct sunlight.
2. Do not use it on the part where you have a scar, eczema or dermatitis.
3. Topical use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of infants or children's reach.

INDICATIONS & USAGE

Indication and usage:
1. Store in refregerator at or below 6 degrees Celsius.
2. Do not put it in extremely hot or cold places or where exposed to direct sunlight.

DOSAGE & ADMINISTRATION

Dosage and administration:
Apply after washing face.
Gently mix AAPE ampoule I with AAPE ampoule II and apply AAPE to skin several times.
Once opened and mixed, the formular must be used within 3 hours.
Single Use Only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AAPE SKIN AMPOULE 
allantoin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62041-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.03 mg  in 6 
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Mannitol (UNII: 3OWL53L36A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62041-010-016 in 1 CARTON; Type 0: Not a Combination Product08/01/201403/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/201403/01/2019
Labeler - PROSTEMICS Co., Ltd. (689605919)
Registrant - PROSTEMICS Co., Ltd. (689605919)
Establishment
NameAddressID/FEIBusiness Operations
PROSTEMICS Co., Ltd.689605919manufacture(62041-010)

Revised: 5/2019
 
PROSTEMICS Co., Ltd.