RAMOSU KINDAL BUTTER BALM- glycerin cream 
RaMoSu

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

glycerin

caprylyl glycol, centella asiatica, etc.

for 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


label

RAMOSU KINDAL BUTTER BALM 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70465-0008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70465-0008-115 g in 1 CANISTER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/04/2016
Labeler - RaMoSu (689055324)
Registrant - RaMoSu (689055324)
Establishment
NameAddressID/FEIBusiness Operations
RaMoSu689055324manufacture(70465-0008)

Revised: 2/2016
Document Id: 2c54d6d7-71df-0403-e054-00144ff8d46c
Set id: 2aff7640-21e5-6daf-e054-00144ff8d46c
Version: 2
Effective Time: 20160222
 
RaMoSu