ULTRA SOOTHING FORMULA- dimethicone cream

Ultra Soothing Formula by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Dimethicone

INACTIVE INGREDIENT

Water, Beeswax, etc

PURPOSE

Skin Protectant - Soothing, Moisturizing

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

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 FORMULA 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71638-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71638-0009-1	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/02/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/02/2018

Labeler - Dermafirm INC. (690171603)

Registrant - Dermafirm INC. (690171603)

Establishment
Name	Address	ID/FEI	Business Operations
Dermafirm INC.		690171603	label(71638-0009) , pack(71638-0009) , manufacture(71638-0009)