OXY STEM M- dimethicone cream

OXY STEM M by

Drug Labeling and Warnings

OXY STEM M by is a Otc medication manufactured, distributed, or labeled by ULAB, U-LAB Switzerland AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: DIMETHICONE 14.12%

INACTIVE INGREDIENT

Inactive ingredients: Aqua (WATER), Glycerin, Glyceryl Stearate SE, Propylene Glycol, Water (aqua), Cetyl Alcohol, Hydrolyzed Pea, Pentylene Glycol, Glycerin, Carbomer, Triethanolamine, Fructose, Urea, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Glycoproteins, Glutamic Acid, Maltose, Sodium PCA, Sodium Chloride, Sodium Lactate, Trehalose, Allantoin, Valine, Threonine, Sodium Hyaluronate, Glucose

PURPOSE

Purpose: Long-lasting moisturizing and skin smoothing

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Apply morning and night

DOSAGE & ADMINISTRATION

Dosage & Administration: Apply morning and night on clean face and neck after Oxy-Stem M Serum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OXY STEM M 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71276-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	7.06 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71276-080-02	1 in 1 CARTON	03/02/2017
1	NDC: 71276-080-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/02/2017

Labeler - ULAB (688976692)

Registrant - ULAB (688976692)

Establishment
Name	Address	ID/FEI	Business Operations
ULAB		688976692	relabel(71276-080)

Establishment
Name	Address	ID/FEI	Business Operations
U-LAB Switzerland AG		485958743	manufacture(71276-080)