OHL O2 by AMAROS CO., LTD. OHL O2- allantoin spray

OHL O2 by

Drug Labeling and Warnings

OHL O2 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 Ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Sodium PCA, Alcohol Denat., Sodium Hyaluronate, Sodium Citrate, Portulaca Oleracea Extract, Glycine Soja (Soybean) Seed Extract, Anthemis Nobilis Flower/Leaf Extract, Morus Alba Bark Extract, PEG-60 Hydrogenated Castor Oil, Hydrolyzed Collagen, Tocopheryl Acetate, Caprylyl Glycol, Caprylhydroxamic Acid, Citrus Paradisi (Grapefruit) Fruit Extract, Centella Asiatica Extract, Lavandula Angustifolia (Lavender) Oil, Hamamelis Virginiana (Witch Hazel) Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Disodium EDTA, Spirulina Maxima Extract, Piper Methysticum Leaf/Root/Stem Extract, Lavandula Angustifolia (Lavender) Extract, Human Oligopeptide-1, Copper Tripeptide-1, Ceramide 3.

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: The above product can be applied at any time when feel dryness, just spray several times the mist over face and feel the freshness. This product contains over than 20 kinds of Oriental Herbal Extracts. Keep moisture of the skin, calming and improve tone of the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OHL O2 
allantoin spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60899-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.3 mg  in 60 mL

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: 60899-040-01	60 mL 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(60899-040)