NDC | 24765-119-01 |
Set ID | e71e0f0f-20bf-4419-8820-ef2c75be0f0d |
Category | HUMAN OTC DRUG LABEL |
Packager | Pharmacal International Co.,Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- GUJIN BIO SERUM
- PURPOSE
- Indication and Usage
- Dosage and Administration
-
Warnings
■ If following symptoms occur, stop use and consult a doctor: red spots,
swelling, itching, irritation, or symptoms on applied skin under direct
sunlight.
■ Do not use on scarred skin, or if you have dermatitis or eczema
■ Keep away from direct sunlight or heat■ Keep out of reach of children
■ Follow the directions■ Do not use during the pregnancy
-
INACTIVE INGREDIENT
WATER, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, PEG-60
HYDROGENATED CASTOR OIL, LACTIC ACID, HYDROXYETHYLCELLULOSE,
SODIUM LACTATE, HYDROXYETHYL
ACRYLATE/SODIUMACRYLOYLDIMETHYL TAURATE COPOLYMER,
CHLORPHENESIN, FRAGRANCE, L-ARGININE, ALLANTOIN, XANTHAN
GUM, DISODIUM EDTA, CITRIC ACID, SIMMONDSIA CHINENSIS (JOJOBA)
SEED OIL, SQUALANE, ROSA CENTIFOLIA FLOWER WATER, EUCALYPTUS
GLOBULUS LEAF EXTRACT, ASPALATHUS LINEARIS EXTRACT,
CHAMOMILLA RECUTITA (MATRICARIA)FLOWER/LEAF EXTRACT, ALOE
BARBADENSIS LEAF EXTRACT, PENTYLENE GLYCOL, CAPRYLYL GLYCOL,
LACTOBACILLUS/SOYBEAN FERMENT EXTRACT,
SACCHAROMYCES/IMPERATA CYLINDRICA ROOTFERMENT EXTRACT,
SACCHAROMYCES/VISCUM ALBUM (MISTLETOE)FERMENT EXTRACT,
PHENOXYETHANOL, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT,
LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT,
EHTYLHEXYLGLYCERIN, ACETYL HEXAPEPTIDE-8 - PRECAUTIONS
- Produt Label
-
INGREDIENTS AND APPEARANCE
GUJIN BIO SERUM
glycerin, allantoin, hydroxyethylcellulose liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24765-119 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 35 mg in 1 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.5 mg in 1 mL HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) (HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) - UNII:R33S7TK2EP) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG) LACTIC ACID (UNII: 33X04XA5AT) SODIUM LACTATE (UNII: TU7HW0W0QT) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) CHLORPHENESIN (UNII: I670DAL4SZ) ARGININE (UNII: 94ZLA3W45F) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) JOJOBA OIL (UNII: 724GKU717M) SQUALANE (UNII: GW89575KF9) ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY) EUCALYPTUS OIL (UNII: 2R04ONI662) ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU) MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02) ALOE VERA LEAF (UNII: ZY81Z83H0X) PENTYLENE GLYCOL (UNII: 50C1307PZG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SOYBEAN (UNII: L7HT8F1ZOD) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) VISCUM ALBUM FRUIT (UNII: P83EQ521R3) PHENOXYETHANOL (UNII: HIE492ZZ3T) ROSEMARY (UNII: IJ67X351P9) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24765-119-01 3 mL in 1 TUBE; Type 0: Not a Combination Product 06/07/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/07/2018 Labeler - Pharmacal International Co.,Ltd. (557805060) Establishment Name Address ID/FEI Business Operations GreenCos Co., Ltd. 694777325 manufacture(24765-119)