OTC Medication Information: KAEWOON

KAEWOON- glycerin and allantoin gel
RNCARE

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.

Glycerin 3%

Allantoin 0.2%

Skin Protectant

Body Cleansing

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

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

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

KAEWOON glycerin, allantoin gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71237-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 30 mg in 1 mL ALLANTOIN (ALLANTOIN) ALLANTOIN 2 mg in 1 mL

Inactive Ingredients Ingredient Name Strength COCO DIETHANOLAMIDE OLEIC ACID LAURAMIDOPROPYL BETAINE PEG-60 CASTOR OIL RICE BRAN GREEN TEA LEAF POLYSORBATE 80 WATER PROPYLENE GLYCOL SODIUM COCOAMPHOACETATE BUTYLENE GLYCOL EGG PHOSPHOLIPIDS TURMERIC MUNG BEAN ARTEMISIA VULGARIS ROOT ARCTIUM LAPPA ROOT HIPPOPHAE RHAMNOIDES FRUIT CRATAEGUS LAEVIGATA FLOWER RHEUM PALMATUM ROOT BAMBUSA VULGARIS TOP EUCALYPTUS GLOBULUS LEAF HAMAMELIS VIRGINIANA TOP MATRICARIA RECUTITA FLOWERING TOP ASIAN GINSENG PROPOLIS WAX AMINOCAPROIC ACID EDETATE DISODIUM HEXANEDIOL .ALPHA.-TOCOPHEROL ACETATE MEDIUM-CHAIN TRIGLYCERIDES HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) MENTHOL, UNSPECIFIED FORM CITRIC ACID MONOHYDRATE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71237-001-02 1 BOTTLE in 1 CARTON contains a BOTTLE (71237-001-01) 1 NDC:71237-001-01 320 mL in 1 BOTTLE This package is contained within the CARTON (71237-001-02)

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	Operations
RNCARE		694893883	manufacture (71237-001)

Revised: 12/2019 RNCARE