BABY FACE AND BODY CREAMY - dimethicone  lotion 
And Us 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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Drug Facts

dimethicone


water, glycerin, etc.


skin protectant


keep out of reach of the children


apply proper amount to the 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


package label
BABY FACE AND BODY CREAMY 
dimethicone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70353-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70353-0008-1350 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/25/2015
Labeler - And Us Co., Ltd (688461137)
Registrant - And Us Co., Ltd (688461137)
Establishment
NameAddressID/FEIBusiness Operations
And Us Co., Ltd688461137manufacture(70353-0008)

Revised: 12/2015
Document Id: 2631855e-10ec-4235-8af0-12f20421a2b4
Set id: 349df06b-2ff2-4ba9-b60f-9b7307a5c35d
Version: 1
Effective Time: 20151225
 
And Us Co., Ltd