Label: AAPE HAIR AMPOULE- allantoin solution
- NDC Code(s): 62041-020-01
- Packager: PROSTEMICS Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated February 20, 2019
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- ACTIVE INGREDIENT
Active ingredient: Allantoin 0.5%Close
- INACTIVE INGREDIENT
Ampoule I: Human Adipocyte Conditioned Media Extract, Mannitol
Ampoule II: Water, Polyquaternium-7, Propylene Glycol, Glycerin, 1,2-Hexanediol, Lactic Acid, Niacinamide, Polysorbate 20, Glycyrrhiza Glabra (Licorice) Root Extract, Sophora Angustifolia Root Extract, Glycine Soja (Soybean) Seed Extract, Camellia Sinensis Leaf Extract,
Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Polygonum Multiflorum Root Extract, DISODIUM EDTA
Purpose: Skin ProtectantClose
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:Close
Keep out of infants or children's reach.
- INDICATIONS & USAGE
Indication and usage:Close
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:Close
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
- INGREDIENTS AND APPEARANCE
AAPE HAIR AMPOULE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.03 mg in 6 Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Mannitol (UNII: 3OWL53L36A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62041-020-01 6 in 1 CARTON; Type 0: Not a Combination Product 08/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2014 Labeler - PROSTEMICS Co., Ltd. (689605919) Registrant - PROSTEMICS Co., Ltd. (689605919) Establishment Name Address ID/FEI Business Operations PROSTEMICS Co., Ltd. 689605919 manufacture(62041-020)