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

AQUATO PLUS MOISTURE 
glycerin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71567-0003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71567-0003-1	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/13/2017	08/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	11/13/2017	08/12/2019

Labeler - ItoB Co.,Ltd (690099724)

Registrant - ItoB Co.,Ltd (690099724)

Establishment
Name	Address	ID/FEI	Business Operations
Nowcos.Co.,Ltd		689914984	manufacture(71567-0003)

Establishment
Name	Address	ID/FEI	Business Operations
ItoB Co.,Ltd		690099724	pack(71567-0003) , label(71567-0003)

Revised: 8/2019

Document Id: 8fe504d7-5af1-8449-e053-2a95a90ad6a0

34390-5

Set id: 5dd41f9e-87e0-8116-e053-2a91aa0a5bee

Version: 6

Effective Time: 20190812

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