KAEWOON FOR WOMEN- hyaluronic acid, allantoin gel

KAEWOON FOR WOMEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

HYALURONIC ACID 2%

Allantoin 0.2%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Body Cleansing

DOSAGE & ADMINISTRATION

Take an appropriate amount and massage onto 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

Water, Sodium Cocoate, Oleic Acid, Cocamide MIPA, DiGlycerin, Butylene Glycol, Shea Butteramidopropyl Betaine, Hydrolyzed Collagen, Polysorbate85, 1,2-Hexanediol, Sodium Cocoamphoacetate, Oryza Sativa (Rice) Bran Extract, Camellia Sinensis Leaf Extract, Black Strap Powder, 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, Sapindus Mukorossi Fruit Extract, Capryl/Capramidopropyl Betaine, Caprylic/Capric Triglycerid, Polyquaternium-10, Panax Ginseng Root Extract, Hydroxyethylcellulose, Disodium EDTA, Menthol, Mandelic Acid, Propolis Extract, Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KAEWOON FOR WOMEN 
hyaluronic acid, allantoin gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71237-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONIC ACID	20 mg  in 1 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOATE (UNII: R1TQH25F4I)
OLEIC ACID (UNII: 2UMI9U37CP)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
DIGLYCERIN (UNII: 3YC120743U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 85 (UNII: A7F3N56197)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)
RICE BRAN (UNII: R60QEP13IC)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TURMERIC (UNII: 856YO1Z64F)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
HIPPOPHAE RHAMNOIDES SEED (UNII: ZD5PJT4UZF)
RHEUM PALMATUM ROOT (UNII: G025DAL7CE)
BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK)
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)
MATRICARIA CHAMOMILLA ROOT (UNII: BTG5H50X7F)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71237-004-02	1 in 1 CARTON	11/21/2018
1	NDC: 71237-004-01	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		11/21/2018

Labeler - RNCARE (694893883)

Registrant - RNCARE (694893883)

Establishment
Name	Address	ID/FEI	Business Operations
RNCARE		694893883	manufacture(71237-004)