SIMPLY FIRM - FACE AND NECK NON SURGICAL FACE LIFT- dimethicone gel 
CarePluss Pharma S.A. de C.V.

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                      Purpose

Dimethicone 1% ............. skin protectant

Uses: protects from minor skin irritations.

Warnings: For external use only

Do not use

When using this product

Stop use and ask a doctor

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

Other ingredients: Water, Almond Oil, Glycerin, Cetearyl alcohol, Cetearteh-12, Mineral Oil, L-Carnitine, DMAE bitartrate, Sodium Ascorbyl Fosphate, Carbomer, Green Tea extract, Coffe Berry extract, Trietanolamine, Sodium Lauryl Sulphate, Vitamin C, Pepermint Oil, Menthol, Almond scent, Green Tea scent, Coco scent, EDTA disodium.

3 fl oz / 119 mL

label image

SIMPLY FIRM - FACE AND NECK  NON SURGICAL FACE LIFT
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51439-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE.00119 mg  in .119 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
CETYL ALCOHOL 
CETEARETH-12 
MINERAL OIL 
LEVOCARNITINE 
DEANOL 
SODIUM ASCORBYL PHOSPHATE 
GREEN TEA LEAF 
COFFEE BEAN 
TROLAMINE 
SODIUM DODECYLBENZENESULFONATE 
ASCORBIC ACID 
PEPPERMINT OIL 
MINT 
ALMOND 
MELISSA OFFICINALIS 
COCOA 
EDETIC ACID 
METHYLPARABEN 
PROPYLPARABEN 
BUTYLATED HYDROXYTOLUENE 
BUTYLATED HYDROXYANISOLE 
SUNFLOWER OIL 
WATER 
POMEGRANATE SEED OIL 
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51439-002-01.119 mg in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/27/2012
Labeler - CarePluss Pharma S.A. de C.V. (815061551)
Establishment
NameAddressID/FEIBusiness Operations
CarePluss Pharma S.A. de C.V.815061551manufacture(51439-002)

Revised: 4/2013
Document Id: f1525fc3-925b-44f9-a654-ef41076af283
Set id: 019bf296-8fe3-473e-adea-26463820b630
Version: 7
Effective Time: 20130423
 
CarePluss Pharma S.A. de C.V.