KAEWOON- glycerin, 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.

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71237-001_V3

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

image description

KAEWOON 
glycerin, allantoin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71237-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN2 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71237-001-021 in 1 CARTON02/02/2017
1NDC:71237-001-01320 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/02/2017
Labeler - RNCARE (694893883)
Registrant - RNCARE (694893883)
Establishment
NameAddressID/FEIBusiness Operations
RNCARE694893883manufacture(71237-001)

Revised: 10/2021
Document Id: cd8acdc6-073b-5ca3-e053-2a95a90aaf1f
Set id: 516b9ebb-ee12-47c2-afc5-24c7094cca25
Version: 4
Effective Time: 20211004
 
RNCARE