ULTRA SOOTHING MASK 1PC- glycerin liquid

Ultra Soothing Mask 1pc by

Drug Labeling and Warnings

Ultra Soothing Mask 1pc by is a Otc medication manufactured, distributed, or labeled by Dermafirm INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin

INACTIVE INGREDIENT

Water, Butylene Glycol

PURPOSE

Skin protectant

Soothing

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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.

WARNINGS

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

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA SOOTHING MASK 1PC 
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71638-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	1.005 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71638-0010-1	30 g in 1 POUCH; Type 0: Not a Combination Product	09/04/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	09/04/2017

Labeler - Dermafirm INC. (690171603)

Registrant - Dermafirm INC. (690171603)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	label(71638-0010) , pack(71638-0010) , manufacture(71638-0010)