SEAWEED AQUA MASSAGE- allantoin cream

Seaweed Aqua Massage by

Drug Labeling and Warnings

Seaweed Aqua Massage by is a Otc medication manufactured, distributed, or labeled by AMAROS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Sodium Hyaluronate, Cetyl Ethylhexanoate, Aloe Barbadensis Leaf Juice, Triticum Vulgare (Wheat) Germ Oil, Olea Europaea (Olive) Fruit Oil, Cetearyl Alcohol, Sorbitan Olivate, Macadamia Ternifolia Seed Oil, Glyceryl Stearate, Betaine, PEG/PPG-17/6 Copolymer, Simondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Chloride, Tocopheryl Acetate, Panthenol, Propolis Extract, Camellia Sinensis Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Algae Extract, Caprylyl Glycol, Caprylhydroxamic Acid, Beta-Glucan, Lecithin, Disodium EDTA, Ceramide 3, Fragrance.

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. In case of having following symptoms after using this product, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and Usage: 1. Tighten the lid after using it. 2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight. 3. Use it in the morning or evening after washing face.

DOSAGE AND ADMINISTRATION

Dosage and Administration: Apply a small amount of massage cream and rub it into skin, during rubbing the cream, on the skin surface appears droplets of water, which moisturizes and gives a cooling effect to skin. Make-up can be applied over the massage cream. The above product can be applied as night cream or a moisture pack (for 20-30min). There is no sticky or oily feeling after applying of this product, so you may not wash off face after massage procedure.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SEAWEED AQUA MASSAGE 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60899-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	1.5 g  in 300 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60899-010-01	300 g in 1 CARTON; Type 0: Not a Combination Product	09/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/01/2013

Labeler - AMAROS CO., LTD. (690338801)

Registrant - AMAROS CO., LTD. (690338801)

Establishment
Name	Address	ID/FEI	Business Operations
AMAROS CO., LTD.		690338801	manufacture(60899-010)