AQUATO- dimethicone cream

AQUATO by

Drug Labeling and Warnings

AQUATO by is a Otc medication manufactured, distributed, or labeled by ItoB Co.,Ltd, TAENAM MEDICOS CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone

INACTIVE INGREDIENT

Water, Glycerin, Butylene Glycol, etc

PURPOSE

Skin Protectant - Moisturizing, Soothing

KEEP OUT OF REACH OF CHILDREN

keep out or reach of the children

INDICATIONS & USAGE

Dispense the right amount and gently apply onto entire face in accordance with the skin texture.

Allow product to be absorbed by skin.

WARNINGS

1. Do not use in the following cases(Eczema and scalp wounds)
2.Side Effects
1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor
3.General Precautions
1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately
2)This product is for exeternal use only. Do not use for internal use
4.Storage and handling precautions
1)If possible, avoid direct sunlight and store in cool and area of low humidity
2)In order to maintain the quality of the product and avoid misuse
3)Avoid placing the product near fire and store out in reach of children

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUATO 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71567-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71567-0006-1	80 mL in 1 JAR; Type 0: Not a Combination Product	07/05/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/05/2017

Labeler - ItoB Co.,Ltd (690099724)

Registrant - ItoB Co.,Ltd (690099724)

Establishment
Name	Address	ID/FEI	Business Operations
TAENAM MEDICOS CO., LTD		689846359	manufacture(71567-0006)

Establishment
Name	Address	ID/FEI	Business Operations
ItoB Co.,Ltd		690099724	pack(71567-0006) , label(71567-0006)