Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62041-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.03 mg in 6

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Mannitol (UNII: 3OWL53L36A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 62041-010-01	6 in 1 CARTON; Type 0: Not a Combination Product	08/01/2014	03/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/01/2014	03/01/2019

Labeler - PROSTEMICS Co., Ltd. (689605919)

Registrant - PROSTEMICS Co., Ltd. (689605919)

Name	Address	ID/FEI	Business Operations
Establishment
PROSTEMICS Co., Ltd.		689605919	manufacture(62041-010)

Revised: 5/2019

Document Id: 84504a68-2745-402e-97c7-c2b8dfd82fd0

Set id: 7d3835f5-cada-4e17-be6d-dd4548741df7

Version: 4

Effective Time: 20190530

Drug Labeling and Warnings