OXY STEM M- dimethicone cream 
ULAB

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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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

Image of carton

OXY STEM M 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE7.06 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71276-080-021 in 1 CARTON03/02/2017
1NDC:71276-080-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/2017
Labeler - ULAB (688976692)
Registrant - ULAB (688976692)
Establishment
NameAddressID/FEIBusiness Operations
ULAB688976692relabel(71276-080)
Establishment
NameAddressID/FEIBusiness Operations
U-LAB Switzerland AG485958743manufacture(71276-080)

Revised: 3/2017
Document Id: 8712c4a5-f1fb-46c7-aa29-44bd1a8d0ab1
Set id: 31715101-fac0-43b6-b86b-5c8082c73c28
Version: 1
Effective Time: 20170322
 
ULAB