HERBAL SKIN TONER- allantoin cream

Herbal Skin Toner by

Drug Labeling and Warnings

Herbal Skin Toner 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, Alcohol Denat., Butylene Glycol, Betaine, Sophora Angustifolia Root Extract, Portulaca Oleracea Extract, PEG-40 Hydrogenated Castor Oil, Mentha Piperita (Peppermint) Leaf Extract, Symphytum Officinale Leaf Extract, Caprylyl Glycol, Ethylhexylglycerin, Tropolone, Carbomer, Sodium Oleth-8 Phosphate, Octyldodeceth-25, Polysorbate 80, Triethanolamine, Fragrance, Poncirus Trifoliata Fruit Extract, Disodium EDTA.

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 toner to a cotton pad then wipe face and neck. After using toner applying of Vital Fluid Serum is recommended.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HERBAL SKIN TONER 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60899-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.75 mg  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Betaine (UNII: 3SCV180C9W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60899-060-01	150 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(60899-060)