Drug Labeling and Warnings

Drug Details [pdf]

AQUATO PLUS MOISTURE- glycerin lotion 
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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Glycerin

Water, etc

Skin Protectant - Moisturizing, maintain skin moisture barrier

keep out or reach of the children

  • Following the use of base, take a suitable amount on your hand and spread it over your face and body thinly following skin texture
  • rub softly as like doing massage

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

  • store between 10-15 °C (50-59 °F)
  • avoid freezing and excessive heat above 40 °C (104 °F)

for external use only


label

AQUATO PLUS MOISTURE 
glycerin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71567-0003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71567-0003-1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/13/201708/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34711/13/201708/12/2019
Labeler - ItoB Co.,Ltd (690099724)
Registrant - ItoB Co.,Ltd (690099724)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(71567-0003)
Establishment
NameAddressID/FEIBusiness Operations
ItoB Co.,Ltd690099724pack(71567-0003) , label(71567-0003)

Revised: 8/2019
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