UNIWELL NATURAL ESSENCE- dimethicone emulsion

UNIWELL NATURAL ESSENCE by

Drug Labeling and Warnings

UNIWELL NATURAL ESSENCE by is a Otc medication manufactured, distributed, or labeled by uniwell LTD, Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DIMETHICONE 1.875%

PURPOSE

Skin Protectant

INDICATIONS & USAGE

Helps prevent and temporarily protects chafed, chapped or cracked skin.
Helps prevent and protect from the drying effects of wind and cold weather.

DOSAGE & ADMINISTRATION

Apply as needed.

WARNINGS

For external use only.
Do not use on deep or puncture wounds, animal bites, or serious burns.
Stop use and ask a doctor if condition worsen, symptoms last more than 7 days or clean up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Butylene Glycol, Glycerin, 1,2-Hexanediol, Niacinamide, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Arginine, Carbomer, Propanediol, Polyacrylate-13, Hydroxyacetophenone, Polyisobutene, Citrus Aurantium Dulcis (Orange) Oil, Allantoin, Dipotassium Glycyrrhizate, Adenosine, Ethylhexylglycerin, Polysorbate 20, Phenoxyethanol, Theobroma Cacao (Cocoa) Extract, Sorbitan Isostearate, Disodium EDTA, Beta-Glucan, Dextrin, Ecklonia cava Extract, Glycine Soja (Soybean) Sprout Extract, Triticum Vulgare (Wheat) Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Camellia Oleifera Leaf Extract, Magnolia Liliflora Flower Extract, Eugenia Caryophyllus (Clove) Bud Extract, Sophora Japonica Flower Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Alcohol, Phenoxyethanol, Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIWELL NATURAL ESSENCE 
dimethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71502-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.937 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
1,2-Hexanediol (UNII: TR046Y3K1G)
NIACINAMIDE (UNII: 25X51I8RD4)
Squalane (UNII: GW89575KF9)
Arginine (UNII: 94ZLA3W45F)
Propanediol (UNII: 5965N8W85T)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
2-HYDROXYACETOPHENONE (UNII: DQ1N9R01IA)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ORANGE OIL (UNII: AKN3KSD11B)
Allantoin (UNII: 344S277G0Z)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Adenosine (UNII: K72T3FS567)
Ethylhexylglycerin (UNII: 147D247K3P)
Polysorbate 20 (UNII: 7T1F30V5YH)
COCOA (UNII: D9108TZ9KG)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ECKLONIA CAVA (UNII: UXX2N5V39P)
SOYBEAN (UNII: L7HT8F1ZOD)
WHEAT SPROUT (UNII: 3K32950CI0)
BROCCOLI SPROUT (UNII: 128UH9LOAE)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
MAGNOLIA LILIIFLORA FLOWER (UNII: SVM28292LH)
CLOVE (UNII: K48IKT5321)
STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LEMON OIL (UNII: I9GRO824LL)
ALCOHOL (UNII: 3K9958V90M)
Phenoxyethanol (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71502-002-02	1 in 1 PACKAGE	06/12/2017
1	NDC: 71502-002-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/12/2017

Labeler - uniwell LTD (694646565)

Registrant - uniwell LTD (694646565)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmecca Korea Co., Ltd.		688830827	manufacture(71502-002)