SELLA NATURAL BABY - glycerin lotion 
Sella Natural Cosmetics 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

glycerine


water, butylene glycol, panthenol etc


skin protectant


keep out of reach of the children

apply to the skin and rub gently and wash away


・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


for external use only

package label
SELLA NATURAL BABY 
glycerin lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69603-0801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69603-0801-1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/2014
Labeler - Sella Natural Cosmetics Co.,Ltd. (687563333)
Registrant - Sella Natural Cosmetics Co.,Ltd. (687563333)
Establishment
NameAddressID/FEIBusiness Operations
Sella Natural Cosmetics Co.,Ltd.687563333manufacture(69603-0801)

Revised: 2/2015
Document Id: 36f1cee4-1fa7-48aa-9a31-b2000ecd59e8
Set id: 28c0416f-0bd7-4088-834c-2a2dab7a244f
Version: 1
Effective Time: 20150211
 
Sella Natural Cosmetics Co.,Ltd.