ULTRA SOOTHING FORMULA- dimethicone cream 
Dermafirm INC.

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, Beeswax, etc

Skin Protectant - Soothing, Moisturizing

keep out of reach of the children

After using toner, apply this lotion on your face.
Gently spread and tap.

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

ULTRA SOOTHING FORMULA 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71638-0009-1200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/02/2018
Labeler - Dermafirm INC. (690171603)
Registrant - Dermafirm INC. (690171603)
Establishment
NameAddressID/FEIBusiness Operations
Dermafirm INC.690171603label(71638-0009) , pack(71638-0009) , manufacture(71638-0009)

Revised: 4/2018
Document Id: 68d656e4-9778-4fe2-e053-2a91aa0a9fab
Set id: 68d656e4-9777-4fe2-e053-2a91aa0a9fab
Version: 1
Effective Time: 20180401
 
Dermafirm INC.