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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:51439-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE .00119 mg  in .119 mg
Inactive Ingredients
Ingredient Name Strength
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)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
COCOA (UNII: D9108TZ9KG)  
EDETIC ACID (UNII: 9G34HU7RV0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
WATER (UNII: 059QF0KO0R)  
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:51439-002-01 .119 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(51439-002)

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.