Label: AAPE SKIN AMPOULE- niacinamide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62041-250-01 - Packager: PROSTEMICS Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated August 26, 2019
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Water, Butylene Glycol, Glycerin, Sorbitol, Hydroxyacetophenone, Propanediol, Xanthan Gum, Allantoin, Adenosine, Caprylhydroxamic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Camellia Sinensis Leaf Extract, Disodium EDTA, Sophora Angustifolia Root Extract, Angelica Gigas Root Extract, Panax Ginseng Root Extract, Cnidium Officinale Root Extract, Glycine Max (Soybean) Seed Extract, Polygonum Multiflorum Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-5 - PURPOSE
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WARNINGS
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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AAPE SKIN AMPOULE
niacinamide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-250 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide 0.12 g in 6 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62041-250-01 6 mL in 1 CONTAINER; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/01/2019 Labeler - PROSTEMICS Co., Ltd. (689605919) Registrant - PROSTEMICS Co., Ltd. (689605919) Establishment Name Address ID/FEI Business Operations Prostemics Co., Ltd. Factory 695687674 manufacture(62041-250)