SIMPLY FIRM EYE - 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.

2 fl oz / 60 mL

label image

SIMPLY FIRM EYE - NON-SURGICAL FACE LIFT 
dimethicone gel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51439-001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.6 mg  in 60 mg
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALMOND OIL (UNII: 66YXD4DKO9)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
MINERAL OIL (UNII: T5L8T28FGP)  
LEVOCARNITINE (UNII: 0G389FZZ9M)  
DEANOL (UNII: 2N6K9DRA24)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
COFFEE BEAN (UNII: JFH385Y744)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MINT (UNII: FV98Z8GITP)  
ALMOND (UNII: 3Z252A2K9G)  
COCONUT (UNII: 3RT3536DHY)  
LIME (CITRUS) (UNII: 8CZS546954)  
EDETIC ACID (UNII: 9G34HU7RV0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51439-001-01 60 mg in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/27/2012
Labeler - CarePluss Pharma S.A. de C.V. (815061551)
Establishment
Name Address ID/FEI Business Operations
CarePluss Pharma S.A. de C.V. 815061551 manufacture(51439-001)

Revised: 4/2013
Document Id: d12e00d9-1373-4c8e-accc-8c24c2dbd14d
Set id: dfa588ae-1f3a-4a8f-be0f-027b0938fb11
Version: 2
Effective Time: 20130423
 
CarePluss Pharma S.A. de C.V.