Label: ROYAL GINSENG ESSENCE- niacinamide liquid
Contains inactivated NDC Code(s)
NDC Code(s): 75694-0003-1
- Packager: Green Life Agricultural Corporation
- 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.
Updated December 5, 2020
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- ACTIVE INGREDIENT
PEG-7 Glyceryl Cocoate
Panax Ginseng Leaf/Root/Stem Extract
1,2-hexanediol, Caprylyl Glycol
Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Polyglyceryl-10 Laurate, Polyglyceryl-4 Laurate, Caprylyl/Capryl Glucoside
■ if following abnormal symptoms persist, discontinue use
Irritation around the eyes, ears, mucous membranes, including the mouth, under the skin irritation and rashes
■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.
It is not recommended to use this one areas that have been medically treated with a cast or bandage.
■ Do not use in combination with soap or antibacterial cleansing agents.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ROYAL GINSENG ESSENCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75694-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALLANTOIN (UNII: 344S277G0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75694-0003-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/04/2020 Labeler - Green Life Agricultural Corporation (694822215) Registrant - Green Life Agricultural Corporation (694822215) Establishment Name Address ID/FEI Business Operations Bioncell Co., Ltd 688438655 manufacture(75694-0003)