Label: AAPE HAIR AMPOULE- panthenol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62041-260-01 - Packager: PROSTEMICS Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated August 26, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
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
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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 HAIR AMPOULE
panthenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62041-260 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol 0.03 g in 6 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62041-260-01 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(62041-260)