Label: KAEWOON- glycerin, allantoin gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71237-001-01, 71237-001-02 - Packager: RNCARE
- 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 October 4, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Cocamide DEA, Oleic Acid, Lauramidopropyl Betaine, PEG-60 Castor Oil, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Shea Butteramidopropyl Betaine, Polysorbate 80, Water, Propylene Glycol, Sodium Cocoamphoacetate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Lecithin, Curcuma Longa (Turmeric) Root Extract, Phaseolus Radiatus Seed Extract, Artemisia Vulgaris Extract, Arctium Lappa Root Extract, Hippophae Rhamnoides Extract, Crataegus Oxyacantha Extract, Rheum Palmatum Root Extract, Bambusa Vulgaris Extract, Eucalyptus Globulus Leaf Extract, Hamamelis Virginiana (Witch Hazel) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Panax Ginseng Root Extract, Propolis Extract, 6-Aminocaproic Acid, Polyquaternium, Disodium EDTA, Black Strap Powder, Hexanediol, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Menthol, Citric Acid, Frageance
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KAEWOON
glycerin, allantoin gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71237-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 2 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE (UNII: 92005F972D) OLEIC ACID (UNII: 2UMI9U37CP) LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233) PEG-60 CASTOR OIL (UNII: VXP26NM2XX) RICE BRAN (UNII: R60QEP13IC) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) TURMERIC (UNII: 856YO1Z64F) MUNG BEAN (UNII: 1LIB31N73G) ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) CRATAEGUS LAEVIGATA FLOWER (UNII: 85EAT04F4H) RHEUM PALMATUM ROOT (UNII: G025DAL7CE) BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY) MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02) ASIAN GINSENG (UNII: CUQ3A77YXI) PROPOLIS WAX (UNII: 6Y8XYV2NOF) AMINOCAPROIC ACID (UNII: U6F3787206) EDETATE DISODIUM (UNII: 7FLD91C86K) HEXANEDIOL (UNII: ZIA319275I) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71237-001-02 1 in 1 CARTON 02/02/2017 1 NDC:71237-001-01 320 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/02/2017 Labeler - RNCARE (694893883) Registrant - RNCARE (694893883) Establishment Name Address ID/FEI Business Operations RNCARE 694893883 manufacture(71237-001)
