KAEWOON- glycerin, allantoin gel

KAEWOON by

Drug Labeling and Warnings

KAEWOON by is a Otc medication manufactured, distributed, or labeled by RNCARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 3%

Allantoin 0.2%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Body Cleansing

DOSAGE & ADMINISTRATION

Take an appropriate amount and massage onto scalp/body for about 60 seconds and rinse with water

WARNINGS

In case of eye contact, immediately rinse with water

Stop use if unusual redness, swelling, soreness or irritation occur

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

INGREDIENTS AND APPEARANCE

KAEWOON 
glycerin, allantoin gel

Product 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
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	30 mg  in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 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)