ULTRA SOOTHING MASK 1PC- glycerin liquid 
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

Glycerin

Water, Butylene Glycol

Skin protectant

Soothing

keep out of reach of the children

  1. Prepare your skin with cleansing or toner.
  2. Remove from the packet and apply mask over the face.
  3. Leave it on your face for 15 to 20 minutes, and remove it.
  4. Gently tap the remaining contents on the face to absorb it into 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

ULTRA SOOTHING MASK 1PC 
glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71638-0010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN1.005 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71638-0010-130 g in 1 POUCH; Type 0: Not a Combination Product09/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34709/04/2017
Labeler - Dermafirm INC. (690171603)
Registrant - Dermafirm INC. (690171603)
Establishment
NameAddressID/FEIBusiness Operations
Dermafirm INC.690171603label(71638-0010) , pack(71638-0010) , manufacture(71638-0010)

Revised: 9/2017
Document Id: 58574c76-fcae-1590-e053-2991aa0a2caa
Set id: 58574c76-fcad-1590-e053-2991aa0a2caa
Version: 1
Effective Time: 20170904
 
Dermafirm INC.