AQUATO- dimethicone cream 
ItoB Co.,Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dimethicone

Water, Glycerin, Butylene Glycol, etc

Skin Protectant - Moisturizing, Soothing

keep out or reach of the children

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

Allow product to be absorbed by skin.

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

for external use only


label

AQUATO 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71567-0006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71567-0006-180 mL in 1 JAR; Type 0: Not a Combination Product07/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/05/2017
Labeler - ItoB Co.,Ltd (690099724)
Registrant - ItoB Co.,Ltd (690099724)
Establishment
NameAddressID/FEIBusiness Operations
TAENAM MEDICOS CO., LTD689846359manufacture(71567-0006)
Establishment
NameAddressID/FEIBusiness Operations
ItoB Co.,Ltd690099724pack(71567-0006) , label(71567-0006)

Revised: 6/2018
Document Id: 6f25025d-822c-9792-e053-2a91aa0a6192
Set id: 6f25025d-822b-9792-e053-2a91aa0a6192
Version: 1
Effective Time: 20180601
 
ItoB Co.,Ltd