AAPE Hair Ampoule: Package Insert and Label Information

AAPE HAIR AMPOULE- panthenol liquid
PROSTEMICS Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Panthenol 0.5%

INACTIVE INGREDIENT

[Powder] MANNITOL, Human Adipose Derived Mesenchymal Cell Exosomes.

[Solvent] Water, Alcohol, Propylene Glycol, Glycerin, Lactic Acid, Hydroxyacetophenone, Propanediol, Polyquaternium-7, Niacinamide, Polysorbate 20, Butylene Glycol, Caprylhydroxamic Acid, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Sodium Benzoate

PURPOSE

Hair elasticity

WARNINGS

For external use only
1. Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product
2. Do not apply to open wounds.
3. Avoid contact with eyes.
Storage and handling
4. Keep in the refrigerator at 2-6°C.
5. Keep out of reach of children.
6. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Improves effects of hair elasticity.

Directions

Gently mix with AAPE powder to dissolve the mixture.
Take proper amount and gently apply onto the scalp

QUESTIONS

www.prostemics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AAPE HAIR AMPOULE panthenol liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-330 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (PANTHENOL) Panthenol 0.5 g in 100 mL

Inactive Ingredients Ingredient Name Strength Water Alcohol

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62041-330-02 6 CONTAINER in 1 CARTON contains a CONTAINER (62041-330-01) 1 NDC:62041-330-01 6 mL in 1 CONTAINER This package is contained within the CARTON (62041-330-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2021

Labeler — PROSTEMICS Co., Ltd. (689605919)

Registrant — PROSTEMICS Co., Ltd. (689605919)

Establishment
Name	Address	ID/FEI	Operations
Prostemics Co., Ltd. Factory		695687674	manufacture (62041-330)

Revised: 05/2021 PROSTEMICS Co., Ltd.